Abstract:
A method of providing items required for a complex drug regimen. In a preferred embodiment the method includes the steps of disposing a plurality of different drugs in corresponding drug compartments within a container; and providing drug identification information visually associated with each drug compartment containing a drug. The invention also includes a kit for a complex drug regimen. In a preferred embodiment the kit includes a kit container including a plurality of drug compartments, each drug compartment adapted to contain a drug; a plurality of different drugs disposed in the drug compartments; and drug identification information visually associated with each drug compartment containing a drug.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The invention relates generally to kits for complex drug regimens and methods of providing complex drug regimen items, such as methods and kits for fertility treatment regimens.  
         [0002]     Fertility enhancement treatment requires the self-administration of a variety of drugs in a prescribed manner, order and dosage according to a specified schedule. Mistakes in the manner, order and/or dosage of fertility drugs may result in a reduced efficacy of the treatment.  
         [0003]     More significantly, the psychological stress level of the woman undergoing fertility enhancement treatment can affect the outcome of the treatment. Higher levels of psychological stress have been linked to reduced positive outcomes. See, e.g., “DeStress for (Fertility) Success,” HealthScoutNews Jun. 29, 2001; “What Is the Stress/Infertility Connection?”, an online chat dated Jun. 2, 2003 and viewable at http://www.resolve.org/main/national/bboard/chat030602.jsp.  
         [0004]     Koestermann et al. U.S. Patent Application Publ. No. 2003/0211627 describes a method and apparatus for managing a fertility kit. The patent application describes a box with compartments for storing medications and ancillary devices. A doctor&#39;s prescription, orders and instructions may be placed on the inside of the box&#39;s lid.  
         [0005]     One drawback of this and other prior art complex drug regimen kits is their failure to adequately and positively identify the drugs and ancillary devices to be used in the regimen. For example, the order, dosage and timing of the drugs to be taken during fertility treatments can be difficult to follow. While the fertility kit described in the Koestermann et al. patent application provides a prescription, orders or instructions, the kit does not sufficiently tie drug names or other identification information to the corresponding drugs, nor does it tie ancillary devices, such as syringes, to the drugs to which they correspond. Psychological stress from uncertainty about which drugs and/or drug devices in the Koestermann fertility kit to use at a particular point in the treatment regimen, as well as actual treatment errors from choosing the wrong drug or device, can lead to reduced treatment efficacy.  
         [0006]     Another drawback of earlier complex drug regimen kits is their relative inadaptability to changes in the drug regimen, such as changes to the drug contents, container sizes, etc. For example, the Koestermann et al. patent application describes the alteration of drug compartment sizes by cutting foam rubber material to accept the drugs and ancillary devices to be stored in them. This approach to constructing the kit is unduly inflexible and cumbersome.  
       SUMMARY OF THE INVENTION  
       [0007]     The invention provides a complex drug regimen kit and method for providing drugs for a complex drug regimen that is easier to make and use. One aspect of the invention provides a method of providing items required for a complex drug regimen. In a preferred embodiment, the method includes the steps of disposing a plurality of different drugs in corresponding drug compartments within a container and providing drug identification information visually associated with each drug compartment containing a drug. The method may also include the step of labeling the drug compartments with labels to identify drugs to be taken together. In embodiments in which at least two of the drugs are intended to be used together, the disposing step may include the step of associating the at least two drugs with the same label.  
         [0008]     The method may also include the step of altering a drug compartment size prior to completion of the disposing step, such as by adding or removing a wall portion of a compartment from the container or by adding or removing a false bottom to the drug compartment.  
         [0009]     In some embodiments the disposing step may include the step of disposing a drug delivery tool with a drug in a compartment. The invention may also include the step of arranging the drug compartments in a drug compartment arrangement following an intended order of use, and the step of providing drug identification information may include the step of providing drug identification information arranged in an arrangement substantially similar to the drug compartment arrangement. The step of providing instructions may include labeling the container, such as on the container&#39;s lid.  
         [0010]     Another aspect of the invention provides a kit for a complex drug regimen. In a preferred embodiment the kit includes: a kit container comprising a plurality of drug compartments, each drug compartment adapted to contain one or more drugs; a plurality of different drugs disposed in the drug compartments; and drug identification information visually associated with each drug compartment containing a drug. In some embodiments, the kit includes at least one label identifying drugs to be taken together. For example, if at least two of the drugs are intended to be used together, both may be associated with the label. In some embodiments the kit also includes at least one drug delivery tool disposed in a drug delivery compartment along with a drug, such as by placing the drug and its corresponding tool in an order of use within the drug compartment.  
         [0011]     The drug compartments may be arranged in a drug compartment arrangement following an intended order of use, and the drug identification information may be arranged in an arrangement substantially similar to the drug compartment arrangement. In embodiments in which the kit container has a lid, the instructions of use may be disposed on the lid.  
         [0012]     In some embodiments at least one drug compartment is adapted to be altered in size, such as by inserting or removing a drug compartment wall portion or false bottom. The kit may also have a biohazard container. In some embodiments, the kit container may be adapted to conceal most of the biohazard container from view when the kit container&#39;s lid is open. For example, the kit container may be adapted to conceal from view substantially all of the biohazard container except for its lid.  
       Incorporation by Reference  
       [0013]     All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]     The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:  
         [0015]      FIG. 1  is a schematic drawing of a kit for a complex drug regimen according to one embodiment of the invention.  
         [0016]      FIG. 2  is a schematic drawing of a kit for a complex drug regimen according to another embodiment of the invention.  
         [0017]      FIG. 3  is a schematic drawing of the kit of  FIG. 2  showing a cross-section taken along line A-A in  FIG. 2 .  
         [0018]      FIG. 4  is a schematic drawing of the kit of  FIG. 2  loaded in a mailing container.  
         [0019]      FIG. 5  is a schematic drawing of a kit according to another embodiment of the invention, loaded in a mailing container. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures, within the scope of these claims and their equivalents be covered thereby.  
         [0021]      FIG. 1  shows one embodiment of the invention. A complex drug regimen kit  10 , such as a kit containing drugs for fertility treatment, contains drugs  12 , drug delivery devices  14  and other drug regimen materials arranged in drug compartments  16  formed within a box  18  or other container. The drug compartments are preferably arranged in the order in which the drugs are to be taken. Drug delivery devices or other materials needed to be used when taking a particular drug are disposed in the same compartment as the drug, such as an injectable drug and the syringe used when injecting the drug.  
         [0022]     In this embodiment the drugs  12  and their corresponding drug delivery devices  14  are arranged in the order of their use. For example, the syringes  14  used for injectable drugs  12  are placed in front of the corresponding drugs in drug compartment  16 , as shown in  FIG. 1 .  
         [0023]     Drug identification information is also provided in the kit. In a preferred embodiment, the drug identification information is visually associated with the drugs to which it pertains. This visual association makes it easier to follow the drug regimen. For example, box  18  in  FIG. 1  has a lid  20  on which the drug identification information  22  is labeled. To create the visual association between the drug identification information and the corresponding drugs, the drug identification information is arranged in an arrangement substantially similar to the drug compartment arrangement, such as in information areas  24 . This visual association reduces doubt about which drug identification information pertains to which drugs.  
         [0024]     The drug identification information can also be used to create a common language between the patient and health care professionals. For example, one or more of the information area rectangles  24  can be labeled as “Step 1,” “Step 2,” etc., in place of or in addition to listing the drugs and devices contained in the corresponding drug compartments. When the patient is speaking with a health care professional about the drug regimen, the patient can refer to a step rather than try to identify or pronounce the drug or ancillary device name.  
         [0025]     In addition, stress reduction materials  26 , such as pamphlets, video tapes, etc., may be provided in the kit. These stress reduction materials are part of an overall program to increase the efficacy of the drug treatment.  
         [0026]     One particularly stressful aspect of drug regimens that include injectable drugs is the disposable of the syringes or other sharps. State and federal sharps regulations require sharps disposal in clearly marked biohazard containers. Just seeing the biohazard warning label can be a stressor; handling the container itself can be even worse. The kit of this invention therefore provides a sharps disposal biohazard container  28  that is preferably mostly concealed from view by box  18 . In the embodiment of  FIG. 1 , box  18  conceals the sharps container&#39;s biohazard warning label, and sharps may be deposited in the sharps container without removing the container from box  18 . As shown in the embodiment of  FIG. 1 , box  18  conceals substantially all of the biohazard container  28  except for its lid  30 .  
         [0027]     Not all drug regimens are alike, of course. The invention therefore provides a way to customize the kit container to the contents. In the embodiment shown in  FIG. 1 , one or more of the walls  32  of drug compartments  16  may be added or removed to change the shape and size of the drug compartment.  
         [0028]     The invention also provides a way to easily mail a complex drug regimen kit. Lid  20  of box  18  has a hinged flap  34  that folds down over the front  36  of box  18  when lid  20  is closed. Fasteners  38  (such as hook and loop fasteners) are disposed on flap  34  and box front  36  to keep lid  20  closed. Box  18  may then be placed in a mailing container to send to the patient.  
         [0029]     To facilitate mailing, box  18  preferably is sized to fit within a standard express mail box. In one embodiment, box  18  has a dimension along edge  40  of about 16.75 inches or less, a dimension along edge  42  of about 16.75 inches or less and a dimension along edge  44  of about 6.75 inches or less. In another embodiment, box  18  has a dimension of 17.25 inches or less along one side, a second dimension of about 12.25 inches or less along another side and a third dimension of about 2.875 inches or less. Other dimensions corresponding to other mailing container sizes may be used without departing from the invention, of course.  
         [0030]      FIG. 2  shows another embodiment of a complex drug regimen kit. Kit  100  has a container  102  with a plurality of drug compartments. The drug compartments are grouped to identify drugs to be taken together, such as drugs to be taken within the same time period or as part of the single step of a complex drug regimen. In this embodiment, the drug compartments are labeled to show groupings of related drugs and drug devices. Thus, drug compartment  104  has a label  106 ; drug compartments  108 ,  110  and  112  have a label  114 ; drug compartments  116  and  118  have a label  120 ; drug compartments  122 ,  124 ,  126 ,  128  and  130  have a label  132 ; and drug compartments  134 ,  136  and  138  have a label  140 . In addition to helping group the drugs and drug devices by order of use, the labels also provide a common language between the patient and a healthcare professional with regard to the drugs and drug devices by providing a convenient way of referring to the drugs and devices without having to use medical terms or chemical names.  
         [0031]     For example, a fertility kit made and used according to this invention could be assembled as follows: Label  106  reads “Step 1,” and drug compartment  104  contains drugs and devices relating to one particular phase of a fertility treatment, ovarian control. The corresponding drug identification information is shown in Table 1, where the ovarian control medications are identified under a similar label reading “Step 1”. Note that in this embodiment the drug identification information is set forth in a format that mimics the layout of the kit&#39;s container. This drug identification information may be disposed on the inside of the container&#39;s lid, as in the  FIG. 1  embodiment, or may be provided with the kit as a separate piece. If a patient has a question about the drugs taken in this phase of the treatment, she may simply refer to the “Step 1 drugs” instead of having to use their chemical names. This common and easy to use language reduces the stress associated with fertility treatments and helps increase the likelihood of a positive treatment outcome. Use of a common language also reduces the amount of time spent by patients and their health care providers during telephone calls, training sessions, etc.  
                                                                                                                                   TABLE 1                           STEP 1                Ovarian Control           As Needed:           One of these           medicines:           Lupron           Synarel            STEP 2                A. Stimulation Medicines           One or two of these medicines:           Gonal F           Gonal F Multidose           Follistim           Bravelle           Repronex           Pergonal           B. Antagonist Ovarian Control           If Skipped Step 1 then also one of these           medicines:           Antagon           Cetrotide           C. As Needed           Viagra Suppositories                Syringes &amp; Mixing   Injection Needles           Needles For   and Gauze Pads           Stimulation Medicines   for Stimulation               Medicines            STEP 3                As Needed:           Antibiotics for male           Other pills           HCG Medication                Syringe &amp;   Injection           Mixing   Needle           Needle   For HCG           For HCG            STEP 4                As Needed:           Progesterone Pills           Unused space           As Needed:           Injectable Progesterone                Syringes &amp;   Injection           Mixing Needles   Needles           For   For           Progesterone   Progesterone            ALL STEPS                As Needed:           Antibiotics           Baby Aspirin           Alcohol Pads           Sharps           For needle           disposal only                      
 
         [0032]     Continuing the example, label  114  reads “Step 2,” and the drugs and devices in the corresponding drug compartments  108 ,  110  and  112  contain drugs and devices related to another phase of the fertility treatment; label  120  reads “Step 3,” and the drugs and devices in corresponding drug compartments  116  and  118  relate to yet another phase of the fertility treatment; and label  132  reads “Step 4,” and the drugs and devices in corresponding drug compartments  122 ,  124 ,  126 ,  128  and  130  relate to still another phase of the fertility treatment. Finally, label  140  reads “All Steps,” meaning the drugs and devices in drug compartments  134 ,  136  and  138  may be used during any or all phases of the fertility treatment.  
         [0033]     As in the embodiment of  FIG. 1 , the kit container of this embodiment may be customized by changing the size and shape of the drug compartments, such as by adding and/or removing drug compartment walls. In addition, a false bottom may be added to any drug compartment of part of a drug compartment to raise a drug or drug device up, e.g., level with other kit contents. Thus, as shown in  FIG. 3 , false bottoms  142  and  144  have been added to drug compartments  112  and  130 , respectively. In addition, inserts may be placed within a drug compartment to hold and support a drug bottle, device, etc., such as insert  146  in drug compartment  116 , as shown in  FIG. 2 .  
         [0034]      FIG. 4  shows a complex drug regimen box  200  disposed within a mailing container  202 . As shown, mailing container  202  is a standard overnight shipping box having one or more flaps  204  which, when opened, expose complex drug regimen box  200 . To facilitate removal of box  200  from mailing container  202 , one or more tabs  206  are attached to box  200 , such as by punching out portions of box lid  208 . Tabs  206  provide grips for removal of box  200  from container  202 . Alternatively, a strap may be wrapped around three sides of box  200  within mailing container  202  with the ends of the straps extending from the open end of mailing container  202 .  
         [0035]      FIG. 5  shows a complex drug regimen tray  300  disposed in a mailing container  302 , such as a standard overnight shipping box. Once again, tabs  304  are attached to tray  300  to facilitate removal of tray  300  from mailing container  302 .