Abstract:
A portfolio for organizing and managing the storage, access and administration of prescription and/or over-the-counter medications. The portfolio that includes various storage mechanism, holders and tools that can be used for managing a patient&#39;s medications. The portfolio is a two-sided brief-case like device that can be secured in a closed position, or opened to gain access to the interior of the portfolio. The portfolio may include multiple pockets on the outside for storing various items, and a variety of pockets, sleeves, receptors and Velcro or hook and loop structures for receiving and holding various elements such as a pill dispenser, containers, pill bottles, etc. The portfolio can be pre-configured or configurable by including an interior that includes Velcro or hook and loop surfaces that can receive and securely hold various elements, such as medicine bottle receptors, pockets, sleeves, pill dispensers, communication devices, pouches, etc.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is related to the United States design application that was filed concurrently herewith, bearing the title MEDICINE PORTFOLIO ORGANIZER, identified by attorney docket number 20064.1020 and filed under customer number 35856, which application is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    According to the Institute of Medicine&#39;s Jul. 20, 2006 report bearing the title of PREVENTING MEDICATION ERRORS: QUALITY CHASM SERIES”, it is estimated that in “any given week, four out of five adults in the United States will use prescription medicines, over-the-counter drugs, or dietary supplements of some sort, and nearly one-third of adults will take five or more different medications”. “Statistics prove prescription drugs are 16,400% more deadly than terrorists”. This was the title of an article published by Jessica Fraser on Jul. 5, 2005 on the NATRUALNEWS website which can be found at the URL of www&lt;dot&gt;naturalnews&lt;dot&gt;com. At the time the article was written, the author claimed that over 750,000 people die in the United States every year from conventional medicine mistakes with about 106,000 to 200,000 of these deaths being attributed to prescription drugs related issues. In the Institute of Medicine&#39;s Jul. 20, 2006 report, several reported statistics were provided with regards to adverse drug events (ADE) or injuries due to medication. For instance, between 380,000 to 450,000 ADEs were estimated to occur in hospitals but, the committed believed that these numbers were underestimates. The report stated that one study calculated that 800,000 preventable ADEs occure each year in long-term care facilities while another that among outpatient Medicare patients, over 530,000 preventable ADEs occur per year. These statistics are exacerbated by our “take a pill to cure the ill” culture combined with the pharmaceutical ads that flood into our homes on prime time TV. 
         [0003]    An article by Michael A. Steinman, MD and Joshph T. Hanlon, PharmD, MS bearing the title MANAGING MEDICATIONS IN CLINICALLY COMPLEX ELDERS “THERE&#39;S GOT TO BE A HAPPY MEDIUM” highlights the risks and issues involved in ADEs related to elderly patients having multiple medications. The article further addresses the issue by posing several needs in the art. First, a systematic approach to approaching prescribing is essential. Second, an essential first step is to know what the patient is actually taking right now, and to clarify what goals you are trying to achieve by prescribing drugs. Third, it is critical to individualize care based on what benefits and harms a patient is actually experiencing from their drugs. 
         [0004]    “Medication Non-Compliance Estimated to Result in More Than 300,000 Deaths Each Year” was the title of an article posed by Kathy Wetters on Oct. 17, 2010 on the RIGHT AT HOME website. In this article, Ms. Wetters states “Medication non-compliance is becoming one of the most expensive and deadly problems in healthcare today. Hospital costs due to patient non-compliance are estimated at $8.5 billion annually. And with more than 300,000 deaths annually resulting from non-compliance, healthcare professionals, caregivers and Americans are left searching for new ways to fight this avoidable issue”. 
         [0005]    In an article published by FierceHealthcare bearing the title of PATIENTS NOT TAKING MEDICATIONS COST $300B, May 27, 2011 it is stated that the lack of prescription medication adherence costs between $250 and $300 billion annually. Supporting this position, the article cites a report from Express Scripts&#39; released in April of 2011 determining that patients not taking their precribeed medications costs roughly $259 billion per year in emergency room and docober visits, as well as inpatient hospitalizations. 
         [0006]    The website www&lt;dot&gt;abovetheinfluence&lt;dot&gt;com is a web campaign sponsored by the National Youth Anti-Drug Media Campaign and is directed to provide information about drug abuse, overdosing, and non-compliance. With regards to prescription drugs, ABOVETHEINFLUENCE writes: 
         [0007]    “Prescription drugs are medicines that are prescribed to a patient by a doctor to manage pain, treat or cure a health condition such as pain, mental disease, diabetes, cancer, or common infections. These drugs are regulated by the Food and Drug Administration (FDA) and are shown to have medical benefits when prescribed and taken exactly as directed by a health provider. For people who are suffering, these drugs allow them to control their symptoms, cure or treat their diseases, control pain, or fight an infection. However, these medicines are only safe when taken exactly as directed by a doctor, healthcare provider, or as indicated on the packaging. This includes following directions on dosages, how often to take these drugs, and never taking any drug that is not prescribed for you.” 
         [0008]    “Taking prescription drugs that are not prescribed to you—or taking them in any way other than directed by a doctor—is considered non-medical use or abuse and can be as dangerous as taking an illegal drug, such as cocaine or heroin. “Misuse” of a prescription drug is taking it to treat a medical condition but not as directed by a doctor or packaging; “abuse” is taking prescription drugs with the sole intention of getting high. When misused or abused, many prescription drugs can be as dangerous and addictive as “street” drugs. In recent years, there has been a dramatic increase in the number of poisonings and even deaths associated with the abuse and misuse of prescription drugs, including prescription painkillers and anti-depressants.” 
         [0009]    “In other words, even if a medication is prescribed to you, taking larger doses than prescribed, taking it more often than directed, or using it in a way that it is not intended, is abuse and can also lead to severe health consequences and addiction. Between 1995 and 2005, treatment admissions for dependence on prescription pain relievers such as oxycodone (OxyContin) and hydrocodone/acetaminophen (Vicodin) grew more than 300 percent.” 
         [0010]    “Taking prescription drugs without a prescription, not taking them as directed, or mixing them with alcohol are all unsafe and potentially deadly. A 2008 study based on 224,355 U.S. death certificates for which people died from medication errors showed that there was a 3,196 percent increase between 1983 and 2004 in deaths at home from combining prescription drugs with alcohol and/or street drugs.” 
         [0011]    “Additionally, getting prescription drugs without a prescription, called “diversion” is illegal and may put you at risk for arrest and prosecution. Regardless of how you acquire a prescription medication, using these types of drugs without a valid prescription—written for you—is unsafe and illegal.” 
         [0012]    The term “noncompliance” is used in medicine particularly in regard to a patient not taking a prescribed medication or following a prescribed course of therapy. For example, “As many as half of ‘failures’ of treatment to bring elevated blood pressure down to normal levels may be due to unrecognized lapses in taking antihypertensive drugs as prescribed, according to a new study by a team of researchers from the University of Lausannne, Switzerland.” (Stephenson J, JAMA 282: 313, 1999) 
         [0013]    Noncompliance may be overt (as with a Christian Scientist who rejects recommended therapy for religious reasons) or covert (as with children who are supposed to take an antibiotic, say they are taking it but are not, as revealed by a blood test to detect that antibiotic). 
         [0014]    For some individuals, the number of medications that they must take can be overwhelming. Having multiple prescriptions with varying dosage schedules and amounts can become confusing. This, coupled by the similarity in the bottles and labeling, the non-descriptive naming conventions, busy schedules, etc., can easily lead to innocent mistakes by an individual that is taking the medicine—innocent mistakes that can be fatal. 
         [0015]    Whether the cause of non-compliance is due to misuse, abuse, diversion or simply human error, it is clear that the problem is epidemic. Thus, there is a need in the art for a system to help reduce medicine non-compliance. 
       BRIEF SUMMARY 
       [0016]    Various embodiments disclosed provide a tool, system, method and/or device to help organize and manage the storage, access and administration of prescription and/or over-the-counter medications. In general, a portfolio that includes various storage mechanism, holders and tools that can be used for managing a patient&#39;s medications. More specifically, in one embodiment, the portfolio is a two-sided brief-case like device that can be secured in a closed position, or opened to gain access to the interior of the portfolio. The portfolio may include multiple pockets on the outside for storing various items, and a variety of pockets, sleeves, receptors and Velcro or hook and loop structures for receiving and holding various elements such as a pill dispenser, containers, pill bottles, etc. In some embodiments, the portfolio is sold in a particular configuration and/or various versions may include different configurations. In other embodiments, the portfolio may be user configurable by including an interior that includes Velcro or hook and loop surfaces that can receive and securely hold various elements, such as medicine bottle receptors, pockets, sleeves, pill dispensers, communication devices, pouches, etc. 
         [0017]    A particular embodiment includes a portfolio for holding medicine and medicine related items. The portfolio includes a first side and a second side. The first side is joined along one edge with the second side. The joint between the first and second side is flexible or hinged, thereby allowing the first side and the second side to be moved in a hinged like fashion away from each other to an open position and towards each other to a closed position. The one or more of the sides includes a plurality of receptors with each receptor configured to receive a pill bottle. One or more of the sides include at least one pocket for holding a notepad; a surface for receiving and holding pill dispenser; and a calendar. A latching mechanism may be included for securing the first side to the second side in the closed position. 
         [0018]    In various embodiments, the first side and the second side may include interior surfaces with at least portions of the interior surfaces including a fastening element for receiving one or more elements. For instance, the fastening element may be Velcro, hook and loop, snaps, buttons, adhesive, loops, buttons, or other fasteners. The received one or more elements include a mating fastening element. For instance, if the fastening element is Velcro hooks, the mating fastening element may be Velcro loops, etc. As an example, the receptor strips may include the mating fastening element and can be secured to the interior surface of the first or second side. Further, one or more of the elements of a receptor strip, a pocket for holding a notepad; a pill dispenser; a note pad, a calendar, a pouch, a communication device, and a writing instrument may include a mating fastening element that can be secured to the interior surface of the first or second side. 
         [0019]    In other embodiments, the plurality of receptor strips may be fixedly secured to the interior surface of the first or second side. Likewise, one or more of the elements of a receptor strip, a pocket for holding a notepad; a fastening element for a pill dispenser; a note pad holder, a calendar holder, a pouch holder, a communication device holder, and a writing instrument holder can be fixedly secured to the interior surface of the first or second side. 
         [0020]    Further, in other embodiments, a combination of removably attached elements and fixedly attached elements may be utilized in the portfolio. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0021]      FIG. 1  is a perspective view of one embodiment of the medication storage and organizer in the form of a portfolio. 
           [0022]      FIG. 2  is a perspective view of the inside of an exemplary embodiment of the portfolio. 
           [0023]      FIG. 3  is a perspective view of an open and populated portfolio in accordance with one embodiment. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0024]    The present disclosure presents a tool, system and method to help reduce medicine non-compliance by, as well as features and aspects thereof, is directed towards providing an organizer that assists individuals in organizing, identifying and tracking their use, storage and dosing of prescription and over-the-counter medications. 
         [0025]    The disclosed embodiments may include functional elements for the storage of prescription and over-the-counter medications (collectively referred to as medications) and a method for clearly labeling and organizing the medications. Further, the disclosed embodiments may include a dosage tracking functional element for sorting, tracking and verifying medication dosages. Even further, various embodiments may include additional functional elements including, but not limited to, a one or more notepads for writing notes, cautions, instructions, questions/concerns to bring to the attention of the individual&#39;s physician, etc., a writing utensil storage element, a calendar, an electronic media and storage receptacle for the same that can contain further information such as instructions, warnings, etc., a calculator for converting measuring units, a dispenser for measuring dosages, a cutter for splitting pills. 
         [0026]    Turning now to the drawings in which like labels represent like elements, various embodiments of medication storage and organizer are presented. 
         [0027]      FIG. 1  is a perspective view of one embodiment of the medication storage and organizer in the form of a portfolio. The portfolio  100  is shown as including a zipper  102  that can be actuated to securely close the portfolio or open the portfolio to allow access to the inside of the portfolio. It will be appreciated that the zipper  102  may include a locking mechanism to prevent unauthorized access. The locking mechanism can be a simple mechanical combination lock, a keyed lock, an electronic lock, etc. It will also be appreciated that the portfolio can be closed using a variety of techniques including snaps, Velcro, straps, buckles, magnets, covering sleeve, or the like, as well as combinations of two or more of these techniques. 
         [0028]    In the illustrated embodiment, the portfolio is shown as including two external pockets  104  and an identification tag  106 . The external pockets  104  can be used for storage of a variety of items including as non-limiting examples, instructions, books, journals, insurance information, insurance cards, prescription cards, HMA cards, etc. Although only two external pockets are illustrated, it should be appreciated that more or fewer pockets can be used in various embodiments. The identification tag  106  allows for the ownership and contact information of the portfolio to be readily accessible and identified without having to gain access to the internal portions of the portfolio. In the illustrated embodiment, the identification tag  106  is illustrated as a card that can receive the owner&#39;s name, address and telephone number. However, it will be appreciated that additional or less information can also be provided. In addition, other forms of an identification tag may also be employed, such as an electronic display. 
         [0029]      FIG. 2  is a perspective view of the inside of an exemplary embodiment of the portfolio. The portfolio  100  is shown as including a top or back section  210 , and a bottom or front section  230 . The top section  210  is connected to the bottom section  230  along a single side using a flexible material or a hinge or a hinging structure. The connection between the top section  210  and the bottom section  230  enables the top section  210  to be moved away from the bottom section  230  into an opened position, or moved towards the bottom section  230  to a closed position. The top section  210  is shown as including multiple storage receptors  214  arranged in three receptor rows  212  of seven receptors  214  each. In addition, the illustrated embodiment includes a general receptor  216 . The receptors  214  may be suitable for receiving and holding a standard pill bottle. The illustrated receptors  214  are shown as being uniform in size and constructed using an elastic band that is tacked to the surface of the top section  210  at periodic intervals to form receptor loops for receiving the pill bottles. The receptor loops can be constructed at a single size that may accommodate small, medium and large pill bottles. However, in some embodiments, different loop sizes may be utilized and intermixed throughout the portfolio. For instance, some pill bottles may be extra large and require a larger receptor loop which would not be able to accommodate or securely hold smaller pill bottles. In addition, a variety of other mechanisms may be used for holding and securing the pill bottles, as well as other elements in the portfolio. For instance, a plurality of clips, similar to the clips used on the bottom of TV trays, microphone holding clips, etc. can be fixedly or removably attached to the interior surface of the portfolio. In such embodiments, the pill bottle can be pressed into or slid into the holding clip and secured in place. In addition, holders similar to those used for batteries can be used for receiving the pill bottles. 
         [0030]    The general receptor  216  can be used for storage of a writing instrument, a tool such as a pill cutter, a dosage measuring device, or the like. It should be appreciated that the illustrated configuration is simply one of a variety of configurations that may be implemented in various embodiments. Some embodiments may use more or fewer medicine bottle receptors  214  and more or fewer general receptors  216 . 
         [0031]    The bottom section  230  is illustrated as including multiple regions for housing various functional components. In the illustrated embodiment, the bottom section  230  includes a Velcro fastener for a pill box  232 , a pocket or flap for receiving a calendar  234 , a pocket or flap for receiving a note pad, a Velcro fastener for receiving a detachable pouch or container, and a pocket or flap  240  for receiving and holding another note pad, a calculator, insurance card, etc. 
         [0032]    The top section  210  and the bottom section  230  each are bordered by a flap  218  and  242  such that the flap of the top section  210  mates with the flap of the bottom section  230  to close the portfolio. As previously presented, the flaps may include a zipper to secure the flaps together as well as other mechanisms. The flaps  218  and  242  can be constructed in a variety of manners. As non-limiting examples, the flaps may be (a) flexible to allow them to be pulled back over the top section  210  or bottom section  230  to aid in accessing the portfolio contents or (b) rigid to ensure protection of the portfolio contents and to help prevent items from falling out of an opened portfolio. 
         [0033]      FIG. 3  is a perspective view of an open and populated portfolio in accordance with one embodiment. The portfolio  100  is shown as including a top or back section  210 , and a bottom or front section  230 . The top section  210  is shown as including multiple storage receptors  214  arranged in three receptor rows  212  of seven receptors  214  each. Each of the receptors  214  is illustrated as being populated with a medicine bottle  314 . In the illustrated embodiment, attachable labels are presented for identifying the type of medication that is stored in a particular receptor  214 . In the illustrated embodiment, the label includes a Velcro strip  310  that can be looped through the receptor strap  214 . The Velcro strip  310  includes a label holder  312  and a label  316  that can be placed into the label holder  312 . It should be appreciated that labels could be included using a variety of other techniques. A few non-limiting examples include a label with a clip, a label holder fixedly attached to the receptors  214 , a dry-erase type material fixedly attached to the receptor  214  or above/below the receptor  214  in such a manner that the medicine bottle would not obstruct its view, labels that can be attached directly to the bottles (either the side, top or bottom), etc. 
         [0034]    In addition, the illustrated embodiment includes one or more general receptors  216 . In the illustrated embodiment, a pen is shown as being inserted into the general receptor  216 . In other embodiments, various tools or other devices can also be accommodated. For instance, a general receptor could be used to hold a cellular telephone, a pager, a personal data assistant (PDA), a notebook computer, an iPad, and/or an emergency transmitter (such as the “I have fallen and I can&#39;t get up” medical alert device), measuring tool, pill cutter, etc. 
         [0035]    The bottom section  230  is illustrated as housing a note pad for listing medication and/or instructions  336 , a pocket for holding a flash drive or memory device, a note pad for writing questions to be asked during a next visit to the doctor or pharmacy, a pill dispenser box including compartments for morning and evening of each day of the week  332  and a calendar  334 . In the illustrated embodiment, the two note pads  336  and  340  and the calendar are held in pockets  236 ,  240  and  234  respectively (see  FIG. 2 ). The pill dispenser  338  and the pouch  338  are secured into position by including mating Velcro on the underside of the pill dispenser and pouch. 
         [0036]    In should be appreciated that in varying embodiments, the elements may be permanently secured or detachable as described. 
         [0037]    In another embodiment of the portfolio, the interior may be fully customizable. This can be accomplished using a variety of techniques. For instance, the entire interior surface may include a hook and loop fastening material. In such embodiments, a portfolio may be sold with a general set of attachments and other attachments or options can be purchased and added separately. For instance, various receptor rows  212  may be included with the portfolio with the underside of the receptor row including a mating hook and loop material. Advantageously, in such a configuration the user can include various rows for various needs. As an example, each receptor row  212  may include various receptor sizes. In some embodiments, each row may focus on a particular receptor size while in other embodiments, receptor rows may include a variety of different receptor sizes. Similarly, the portfolio may be sold with a variety of other elements/devices such as a calendar, a variety of notepads, one or more pockets of varying sizes, one or more pill dispensers, a calculator, etc. 
         [0038]    In another embodiment, rather than a folding portfolio, the portfolio may consist of a single tray and a sleeve that slides over the tray. In operation, the tray may be pulled or slid out of the sleeve to provide access to the interior of the portfolio. The sleeve can be open on two sides to allow the tray to be slid out in either direction or, the sleeve can include only a single opening on one side. In yet other embodiments the tray may include a top, similar to a cigar box, to allow access to the interior of the trey. In some embodiments, the portfolio may resemble a briefcase or a satchel with a carrying handle. In some embodiments, the portfolio may open as presented in  FIGS. 1-3 , but also include a quick access door located over the pill dispenser box to allow ease of access to the pill dispenser box. Similarly, the portfolio may include a drawer that can be pulled open to provide access to the pill dispenser or other elements in the portfolio without requiring the entire portfolio to be opened. 
         [0039]    In some embodiments, the portfolio may include an embedded processor that can be programmed for providing alerts to the user regarding when medications should be taken. In such an embodiment, the processor may include an interface to a computing system for providing such programming. The interface may be a wired or wireless interface, such a WIFI, Bluetooth, etc. An LCD or other type display may be included to provide instructions to the user, such as reminders to take a dosage of medicine, to call in for refills, or the like. 
         [0040]    The portfolio can be constructed from a variety of materials. As non-limiting examples, the portfolio may be constructed of plastic, aluminum, silicone, cloth, GORE TEX, plastic with a cloth covering, as well as combinations or hybrids of any of these materials as well as other materials. 
         [0041]    In some embodiments, the portfolio is constructed to be water proof or water resistant. In other embodiments, the portfolio is designed to easily slide into a refrigerator. In yet other embodiments, the portfolio may include one or more water proof pockets for holding BLUE ICE or similar devices that can be used to maintain the temperature within the portfolio at a particular temperature. In other embodiments, the portfolio may include insulation or a thermal protection. Alternatively, only portions, pockets, or sections of the portfolio may include insulation or thermal protection. Advantageously, such embodiments allow the portfolio to be portable even for medications that require refrigeration. 
         [0042]    Some embodiments of the portfolio may include a pocket, sleeve or chamber for holding a thermos or water bottle. 
         [0043]    In the description and claims of the present application, each of the verbs, “comprise”, “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements, or parts of the subject or subjects of the verb. 
         [0044]    The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art. Further, the drawings and description has shown various elements being attached or affixed to certain areas and certain sides of the portfolio, but it should be appreciated that a variety of configurations may be employed such that any of the described elements can be placed at any location on any side of the porfolio&#39;s interior or exterior. 
         [0045]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described herein above. Rather the scope of the invention is defined by the claims that follow.