Patent Publication Number: US-2012024889-A1

Title: Polypharmacy Co-Packaged Medication Dosing Unit Including Communication System Therefor

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 12/564,017, filed on Sep. 21, 2009 and entitled “Communication System with Partial Power Source”, published on Apr. 1, 2010 as U.S. Publication No. US2010-0081894A1, which is a continuation-in-part application of U.S. patent application Ser. No. 11/912,475 filed Jun. 23, 2008 and entitled “Pharma-Informatics System”, published on Nov. 20, 2008 as U.S. Publication No. 2008-0284599A1 which application is a 371 application of PCT Application No. PCT/US06/16370 filed Apr. 28, 2006 and entitled “Pharma-Informatics System”; which application pursuant to 35 U.S.C. §119 (e), claims priority to the filing dates of: U.S. Provisional Patent Application Ser. No. 60/676,145 filed Apr. 28, 2005 and entitled “Pharma-Informatics System”; U.S. Provisional Patent Application Ser. No. 60/694,078, filed Jun. 24, 2005, and entitled “Pharma-Informatics System”; U.S. Provisional Patent Application Ser. No. 60/713,680 filed Sep. 1, 2005 and entitled “Medical Diagnostic And Treatment Platform Using Near-Field Wireless Communication Of Information Within A Patient&#39;s Body”; and U.S. Provisional Patent Application Ser. No. 60/790,335 filed Apr. 7, 2006 and entitled “Pharma-Informatics System”; the disclosures of which are herein incorporated by reference. 
     This application is related to the following US Applications filed concurrently herewith, the disclosures of which are incorporated herein by reference: U.S. application Ser. No. ______ COMMUNICATION SYSTEM WITH REMOTE ACTIVATION (Attorney Docket No. PRTS-010CON2CIP (PRO-147)); U.S. application Ser. No. ______ COMMUNICATION SYSTEM WITH MULTIPLE TYPES OF POWER (Attorney Docket No. PRTS-010CON2CIP2 (PRO-148)); U.S. application Ser. No. ______ COMMUNICATION SYSTEM USING AN IMPLANTABLE DEVICE (Attorney Docket No. PRTS-010CON2CIP3 (PRO-149)); U.S. application Ser. No. ______ COMMUNICATION SYSTEM WITH ENHANCED PARTIAL POWER AND METHOD OF MANUFACTURING SAME (Attorney Docket No. PRTS-010CON2CIP4 (PRO-150)); and U.S. application Ser. No. ______ COMMUNICATION SYSTEM INCORPORATED IN AN INGESTIBLE PRODUCT (Attorney Docket No. PRTS-010CON2CIP6 (PRO-152)). 
    
    
     INTRODUCTION 
     Patients concurrently taking multiple medications, including prescription and non-prescription drugs, are at greatest risk of polypharmacy consequences. Although polypharmacy may be widespread throughout the general population, it is most common in people with multiple medical conditions. Such patients include the elderly, psychiatric patients, patients multiple drugs concurrently, those with multiple physicians and pharmacies, recently hospitalized patients, individuals with concurrent comorbidities, and those with impaired vision or dexterity, to mention a few. 
     Polypharmacy generally refers to the use of multiple medications by a patient under various circumstances. Sometimes patients use too many forms of medication. Other times, more drugs are prescribed than is clinically warranted. And sometimes, even when all prescribed medications are clinically indicated, there may be too many pills to take for the patient to take. Polypharmacy generally results in increased adverse drug reactions, drug-drug interactions, and higher costs, among other deleterious effects caused by polypharmacy. 
     To address various issues associated with polypharmacy, there is a need to custom-package individual medication dosing units for patients that take multiple medications or a regular basis. There also is a need to track the custom-package individual medication dosing units from the pharmacy to the patient and record the time when the package is opened and the medication dosing event occurs. 
     SUMMARY 
     In one aspect, a custom medication dosing unit is provided. The custom medication dosing unit comprises a housing comprising at least one shell element provided with a generally bottom surface and a circumferential edge extending upwardly from the bottom surface and a portion defining an opening for accommodating at least one medication. A first closure element is provided with a circumferential edge placed on the circumferential edge of the shell element in an adhering and closing manner. At least one medication may be disposed within the opening defined between the portion of the shell element and the first closure element. A circuit module is associated within the first closure element. 
    
    
     
       FIGURES 
         FIG. 1  illustrates one aspect of a system for tracking a polypharmacy custom medication dosing unit and recording a medication event associated therewith. 
         FIG. 2  illustrates one aspect of a system for tracking a polypharmacy custom medication dosing unit and recording a medication event associated therewith. 
         FIG. 3  illustrates one aspect of a system for packaging and tracking a polypharmacy custom medication dosing unit. 
         FIG. 4A  illustrates one aspect of a single dosing unit customized for an individual patient where the single dosing unit package comprises multiple medications. 
         FIG. 4B  is a partial cutaway view of the multiple medication single dosing unit package shown in  FIG. 4A  illustrating a circuit element associated in the closure portion of the housing of the multiple medication single dosing unit package. 
         FIG. 5A  is a diagram illustrating a typical packet of information communicated from an individual patient customized single-dose package. 
         FIG. 5B  is a diagram illustrating a typical packet of information communicated from an individual patient customized multi-dose package. 
         FIG. 6  shows one aspect of a patch. 
         FIG. 7  shows one aspect of an ingestible event marker. 
         FIG. 8  illustrates one aspect of a circuit module. 
     
    
    
     DESCRIPTION 
     In various aspects, the present disclosure is directed generally to an apparatus, system, and method for a patient to collaborate with physicians, pharmacies, and/or drug manufacturers to address issues associated with polypharmacy problems. The apparatus, system, and method provide techniques that facilitate increased interaction between the patient and physicians, pharmacies, and/or drug manufacturers to improve medication dosing, reduce cost, and likely reduce the potentially deleterious consequences of polypharmacy. Accordingly, the present disclosure provides various techniques for patients and doctors informing pharmacists of other medications consumed by the patient. It will be appreciated that the term “medication” as used throughout this disclosure includes various forms of ingestible, inhalable, injectable, absorbable, insertable, infusible, or otherwise consumable medicaments and/or carriers therefor such as, for example, pills, capsules, gel caps, placebos, over capsulation carriers or vehicles, herbal, over-the-counter (OTC) substances, supplements, prescription-only medication, ingestible devices (e.g., ingestible event markers (IEM), ingestible radio frequency identification (RFID) devices, ingestible inductive coils, ingestible magnets), and the like. 
     Generally, in one aspect, the present disclosure provides a personal single or multiple dosing session packages containing multiple medications, which may be prescription or non-prescription medications, co-packaged for a single dosing event. In general terms, a single dosing event may include prescription and non-prescription pharmaceuticals, steroids, vitamins, supplements, pharmaceuticals for co-morbidities (e.g., to address the presence of one or more disorders or diseases in addition to a primary disease or disorder, or the effect of such additional disorders or diseases), ingestible devices (e.g., IEM devices, indicator IEM devices, ingestible RFID tags, ingestible inductive coils, ingestible magnets), to mention a few. 
     A single dosing package may contain a daily medication dosing session or separate morning (am), afternoon (pm), and/or evening medication dosing sessions. In one aspect, the single dosing pre-packaged unit is like a custom blister pack and contains all the medications for a single dosing event contained in a single individual packaged unit. 
     A multiple dosing package may contain a multiple daily medication dosing sessions such as morning (am), afternoon (pm), and/or evening medication dosing sessions or weekly medication dosing sessions in individualized compartments or prepackaged units. In one aspect, the multiple dosing package is like a custom weekly or monthly medication organizer dispenser tray and contains all the medications for a particular period such as day, week, month, where each individual dosing session is pre-packaged individually for the entire period. 
     Each dosing session contained in a single dose or multiple dose pre-packaged unit, whether morning, afternoon, evening, daily, weekly, monthly, and so on, may be custom packaged for an individual patient and may be marked with the name of the patient, the date the pre-packaged unit was packaged, the dosing event (e.g., morning, evening, daily, weekly—M, T, W, Th, F, Sa, Su, and so on), and the contents, for example. In some aspects, the expiration date or shelf life of the medication also may be indicated on the pre-packaged unit. In other aspects, an ingestible device may be contained in the single dose or multiple dose pre-packaged unit and the type of ingestible device (e.g., IEM devices) may be indicated on the pre-packaged unit. 
     For clarity of disclosure, these and other aspects of the present disclosure will now be described in conjunction with the associated figures. Accordingly, turning now to  FIG. 1 , one aspect of a system  100  for tracking a polypharmacy custom medication dosing unit provided in package  102 ,  104  and recording a medication dosing event associated therewith is illustrated. In one aspect, a single-dose package  102  contains a single dosing unit comprising one or more medications  112 . In one aspect, the single dosing unit also may comprise a medication device. In various other aspects, the medication device may comprise any suitable form of medication as defined above (e.g., ingestible, inhalable, injectable, absorbable, insertable, infusible, or otherwise consumable medicaments and/or carriers therefor such as, for example, pills, capsules, gel caps, placebos, over capsulation carriers or vehicles, herbal, over-the-counter (OTC) substances, supplements, prescription-only medication, ingestible devices such as, IEM devices, ingestible RFID tags, ingestible inductive coils, ingestible magnets, and the like). In one aspect, a multi-dose package  104  comprises a plurality of compartments  116  where each of the compartments  116  contains a single dosing unit comprising one or more medications  122 . In one aspect, the single dosing unit in each of the compartment  116  may comprise an ingestible device such as an IEM device, ingestible RFID tag, ingestible inductive coil, ingestible magnet, and the like. In another aspect, the multi-dose package  104  may comprise an additional portion for storing a plurality of IEM devices in separate storage compartments  124 . In  FIG. 1 , the single-dose package  102  is intended for a single medication dose whereas the multi-dose package  104  is intended for multiple medication doses over a period of one week. 
     In the particular aspect of the system  100  shown in  FIG. 1 , the single-dose package  102  and the multi-dose package  104  are shown in communication with a local node  106  via respective wireless media  144 ,  146 . The local node  106  is shown in communication with a remote node  108  via communication link  150 . Furthermore, the single-dose and multi-dose packages  102 ,  104  shown in  FIG. 1  are provided for illustrative purposes only and other configurations may be substituted that fall within the contemplated aspects of the present disclosure. For example, as shown, it will be appreciated that other communication configurations between the single-dose and multi-dose packages  102 ,  104 , the local node  106 , and remote node  108  are contemplated to be within the scope of the present disclosure and accordingly, the appended claims should not be limited in this context. 
     In one general aspect, when a peel-off closure element  114  is removed from the single-dose package  102  a circuit module is activated and generates a signal, which is transmitted to the local node  106 . Similarly, when a closure element  118  of the multi-dose package  104  is opened, another signal is generated and transmitted to the local node  106 . The signal may include any information associated with the single-dose or multi-dose packages  102 ,  104  or the medication contained therein. The local node  106  may act as a local access point to the Internet and communicates the information received from the single and/or multiple medication dosing unit packages  102 ,  104  to the remote node  108 . The remote node  108  may be a physician&#39;s office, pharmacy, drug manufacturer, nutrition center, and the like. These and other aspects of the system will be described in more detail hereinbelow. 
     As shown in  FIG. 1 , in one aspect, a custom medication dosing unit may be contained in a single medication dosing unit package  102 . The single-dose package  102  may contain one or more medications  112  suitable for a single medication dosing event. In the aspect shown in  FIG. 1 , the single-dose package  102  comprises multiple medications  112  customized for an individual patient to be consumed in a single dosing event. 
     In one aspect, the single-dose package  102  may have a small tray-like form factor having a portion  110  (e.g., a central portion) defining an opening to accommodate the medication  112  therein and a peel-off closure element  114 . The single-dose package  102  is suitable for containing one or more medications  112  for a single dosing unit. The package comprises a shell element  103  provided with a bottom surface and a circumferential edge extending upwardly from the bottom surface and the portion  110  defining an opening for accommodating the medication(s)  112 . In one aspect, the bottom surface is generally planar. In other aspects the bottom surface may take any number of suitable configurations. The single-dose package  102  also comprises a closure element  114  provided with a circumferential edge placed on the circumferential edge of the shell element  103  in an adhering and closing manner. In one aspect, the circumferential edge of the shell element  103  may be substantially upright. In other aspects, the circumferential edge of the shell element  103  may be slanted inwardly or outwardly, among other configurations. The closure element  114  is configured to peel-off the shell element  103  for the purpose of peeling off the closure element  114  from the shell element  103  to expose the central portion  110  to provide access to the medication(s)  112 . The closure element  114 , shown in a partially opened peeled back position, is adhered on the open side of the shell element  103  of the housing  103  to seal the medication  112  within the package. The closure element  114  protects the medications  112  from the environment and, in various aspects, provides a moisture barrier, light barrier, and security. In another aspect, padding or nesting features may be provided in the interior opening of the shell element  103  to pad or a nest to receive the medication(s)  112  and prevents them from rattling inside the shell element  103 . The shell element  103  and the closure element  114  may be formed of a variety of polymers, metals, or combinations thereof, and in one aspect the shell element  103  and the closure element  114  may be formed of aluminum. The closure element  114  may be configured to be opened in a relatively easy operation and in one aspect may be opened in one peeling operation by the user. It will be appreciated that other form factors are contemplated to be within the scope of the present disclosure, but are not shown for clarity of disclosure. For example, dual morning/afternoon (am/pm) medication dosing packages, as well as other custom packages such as a blister pack form factor are within the scope of the present of the disclosure. 
     In one aspect, the single-dose package  102  can be pre-packaged and customized for an individual patient by a physician, pharmacy, drug manufacturer, nutrition center, or other third party, or combinations thereof. Since the single-dose package  102  contains individualized daily medication doses specifically customized for the patient, it would be helpful to mark the exterior portion of the single-dose package  102  with the contents thereof. Accordingly, in one aspect, such markings may be provided either on the closure element  114  or portions of the shell element  103  (e.g., exterior sidewalls or bottom portions) in order to mark the single-dose package  102  with customized information associated with the individual patient and/or the medication(s)  112 . The customized information may include, without limitation, the name of the patient, the packaging date, the dosing event (e.g., morning, evening, daily), and the contents of the package, such as the identity of the medication(s)  112  contained inside the single-dose package  102 , for example. In some aspects, the expiration date or shelf life of the one or more medication(s)  112  contained inside the single-dose package  102  may be indicated on the exterior of the single-dose package  102 . In other aspects, the type of IEM device contained inside the single-dose package  102  may be indicated on the exterior of the single-dose package  102 . 
     As shown in  FIG. 1 , in one aspect, the multi-dose package  104  comprises a housing  105  having a plurality of compartments  116  where each of the compartments  116  contains a single dosing unit comprising one or more medications  122 . In one aspect, the single dosing unit contained in each of the compartments  116  may comprise an ingestible device. In another aspect, the multi-dose package  104  may comprise an additional portion for storing a plurality of IEM devices  130 , for example, in separate storage compartments  124 . In  FIG. 1 , the multi-dose package  104  is intended for multiple medication doses over a period of one week. 
     In one aspect, each of the compartments  116  have a shell element provided with a bottom surface and a circumferential edge extending upwardly from the bottom surface and a portion  120  defining an opening for accommodating the medication(s)  122  therein. In one aspect, the bottom surface may be substantially planar. In other aspects the bottom surface may take any number of suitable configurations. In one aspect, the circumferential edge of the shell element may be substantially upright. In other aspects, the circumferential edge of the shell element may be slanted inwardly or outwardly, among other configurations. Each of the compartments  116  of the multi-dose package  104  is labeled with the day of the week (e.g., M, Tu, W, Th, F, Sa, Su). Each of the compartments  116  of the multi-dose package  104  also comprises a closure element  118  provided with a circumferential edge and a tab portion  119  for latching the closure element  118  in a closing manner. The closure element  118  is configured to pivot in an open and closed position. As shown in  FIG. 1  with respect to the Monday (M) compartment, the closure element  118  is in an open position and the remaining closure elements for Tuesday-Sunday (Tu-Su) are in a closed position. Placing the closure element in the open position provides access to the central portion  120  and the medication(s)  122  contained therein. In the closed position, the tab portion  119  portion of the closure element  118  mates with a corresponding edge of the compartment  116  to latch in a closed position. 
     In the closed position, the closure element  118  protects the medication(s)  122  contained in the central portion  120  from environmental factors such as moisture and light and provides security. In another aspect, padding or nesting features may be provided in the interior opening of the shell element to pad or a nest to receive the medication(s)  122  and prevent them from rattling inside the compartment  116 . The housing  105  including the compartments  116  and the closure elements  118  may be formed of a variety of polymers, metals, or combinations thereof, and in one aspect the housing  105  and the closure elements  114  may be formed of a polymer. The closure elements  114  may be configured to be opened in a relatively easy operation and in one aspect may be opened in a single rotatable operation by the user. It will be appreciated that other form factors are contemplated to be within the scope of the present disclosure, but are not shown for clarity of disclosure. For example, dual morning/afternoon (am/pm) medication dosing packages, as well as other custom packages such as a blister pack form factor are within the scope of the present of the disclosure. 
     As previously mentioned, in one aspect the, the multi-dose package  104  may comprise a plurality of compartments  124  for storing a plurality of IEM devices  130 . As shown, the IEM compartments  124  comprise a well  128  for accommodating an ingestible device, such as a single IEM device  130 , as shown, for example. The IEM compartment  124  includes a closure element  126 , shown partially opened, to protect the IEM device  130  from environmental factors such as moisture and light and also provides security before usage. In one aspect, the additional IEM compartments  124  are blister packs where the closure elements  126  are formed of a thin aluminum sheet such that the IEM device  130  can be pushed therethrough for access by the patient. Although the multi-dose package  104  is shown in a weekly dosage configuration, other configurations such as semi-daily (am/pm), monthly dosage, are contemplated within the scope of the present disclosure. 
     In one aspect, the multi-dose unit  104  can be pre-packaged and customized for an individual patient by a physician, pharmacy, drug manufacturer, third party, or combinations thereof. The multi-dose package  104  contains one week&#39;s worth of individualized daily medication doses specifically customized for the patient. In one aspect, the closure element  118 , or portions of the housing  105  (e.g., sidewalls or bottom portion), may be used to mark the multi-dose unit  104  with customized information associated with the individual patient. The customized information may include, without limitation, the name of the patient, the packaging date, the dosing event (e.g., morning, evening, daily), and the contents of the package, such as the identity of the medication(s)  122  contained inside each of the compartments  116 , for example. As shown, the individual compartments  116  of the multi-dose package  104  are marked with the day of the week (e.g., M, Tu, W, Th, F, Sa, Su) in which the patient is to consume the dosing event contained within the central portion  120 . In some aspects, the expiration date or shelf life of the one or more medication(s)  122  may be indicated on an exterior portion of the closure element  118 , or exterior portions of the housing  105 . In other aspects, the type of IEM device  130  contained in the multi-dose package  104  may be indicated on an exterior portion of the closure element  118 , or exterior portions of the housing  105 . 
     In one aspect, the single-dose package  102  and the multi-dose package  104  may comprise electronic circuit module  115  integrated therewith, e.g., the housing  103   105  and/or the closure elements  114 ,  118 . The single- and multi-dose packages  102 ,  104  may include any type of circuit module  115  configured to activate when the closure element  114  has been removed (e.g., by peeling or blistering), transmitting information associated with the single- and/or multi-dose packages  102 ,  104 , and recording a time stamp associated with such event. In various aspects, a sensor element may be provided to detect the when the closure the closure element  114 ,  118  of the single- or multi-dose packages  102 ,  104  is removed from the corresponding shell element  103 ,  116 . 
     In certain aspects, an ingestible device, e.g., the IEM device  130  may be provided in the single- or multi-dose packages  102 ,  104  as part of the single medication dosing unit. When the IEM device is ingested and activated, the IEM device  130  may communicate with the external node  106  to confirm that the single- or multi-dose package  102 ,  104  was opened and that the IEM device  130  was ingested by the patient. Examples of an IEM are described in U.S. patent application Ser. No. 12/564,017, supra. In one example of the IEM. It will be appreciated that the IEM device  130  is presumably ingested along with the other medication(s)  112 ,  122  provided inside the respective single- or multi-dose package  102 ,  104 . Accordingly, the communication indicating that the IEM device  130  was ingested may be employed to confirm at least that the IEM device  130  was ingested and to infer that the other medication(s)  112 ,  122  also were consumed (e.g., ingested, inhaled, injected, absorbed) by the patient. 
     In one aspect, an ingestible device, e.g., the IEM device  130 , may communicate with the circuit module  115  before being ingested by the patient. This may be triggered by a timer mechanism or by a latching or locking mechanism provided on or in the single- or multi-dose packages  102 ,  104 . In various aspects, this communication technique may be useful to confirm that the patient takes the ingestible device within a predetermined time period after opening the package or triggering an alarm. By way of example and not limitation, in one aspect, the ingestible device, e.g., the IEM device  130 , may communicate to the circuit module  115 , or the local node  106  directly, that the single- or multi-dose package  102 ,  104  has been opened. Once the “package open” signal is transmitted, a timer may be initiated. When the patient ingests the ingestible device, the ingestible device communicates to the local node  106  the ingestion event and the timer is reset. If the timer expires, an alarm indication is set. Accordingly, by monitoring the timer status, the local node  106  may provide a confirmation that the patient actually ingested the ingestible device after the single- or multi-dose package  102 ,  104  was opened. Other suitable techniques may be employed other then timers such as direct communication with the local node after the single- or multi-dose package  102 ,  104  is opened and after the ingestion event occurs to confirm the ingestion event. 
     Turning now briefly to  FIG. 8 , in one aspect, the circuit module  115  may include a radio subsystem  800 , a processing subsystem  802 , a memory subsystem  804 , and/or a power subsystem  806 . In one aspect, the circuit module  115  comprises an optional power storage unit  808  (shown in phantom) to receive power from an external source and store the power in the power storage unit  808 . The power storage unit  808  may comprise any suitable energy storage element such as a capacitor, supercapacitor, rechargeable battery cell (or multiple rechargeable battery cells), among other energy storage elements. In various aspects, the energy storage element of the power storage unit  808  may be charged via direct coupling, inductive coupling, electromagnetic coupling, eddy current, solar power, among other suitable energy coupling techniques. In one aspect, an inductive charging device, such as an inductive charging pad, may provide a wireless charging technique similar to that used for mid-sized items such as cell phones, MP3 players, personal; digital assistants (PDAs), tablet computers, and the like. In inductive charging, an adapter equipped with contact points may be attached to a back plate coupled to the power storage unit. When the power storage unit  808  requires a charge, it may be placed on a conductive charging pad. Once the contact points come in contact with the conductive surface of the charging pad, a small current moves through coils located in the charging pad, creating a small magnetic field which is gathered by the contact points of the adapter and converted into energy. The energy gathered is transferred to the rechargeable battery (capacitor or supercapacitor) of the power storage unit  808 , as efficiently as if the device were connected to a wall socket with its regular wired adapter, for example. 
     Turning back now to  FIG. 1 , in one aspect, the electronic circuit module  115  integrated with the single- or multi-dose package  102 ,  104  may include a basic radio circuit including a transmitter, receiver, and/or transceiver to communicate information associated with the single- or multi-dose package  102 ,  104 , such as opening the packages, purchasing, storing, and/or ingesting the IEM device  130 . In certain aspects, the circuit module  115  may include other elements such as digital memory and a processor coupled thereto. The radio portion of the circuit module  115  is configured to communicate with the local node  106  and/or other nearby single- or multi-dose packages located in proximity to the single- or multi-dose package  102 ,  104  over the wireless media  144 ,  146 . In various aspects, the circuit module  115  may be powered by an on-board battery or may be powered by a passive electromagnetic field in a manner similar to the way radio frequency identification (RFID) tags are powered using an external interrogation electromagnetic field without employing an on-board battery. In one aspect, any of the systems such as the patch  214 , the mobile device  216 , and/or the access point  208  may generate an external interrogation signal to power the circuit module  115 . 
     In various aspects, upon opening the closure element  114 ,  118 , the radio of the circuit module  115  is activated and begins transmitting information to the local node  106  and/or to other single- or multi-dose package(s)  102 ,  104  over the wireless media  144 ,  146 . The communication capabilities of the single- or multi-dose package  102 ,  104  provide integrity of supply chain, an interface for physicians such that the physician can select which medication doses (e.g., pills) go into the package, an interface for end users (e.g., patients or personal caregivers) to configure the types of medication doses or co-ingested IEM devices  130  to include in the single- or multi-dose package  102 ,  104 . The information includes any information suitable for identifying the single- or multi-dose package  102 ,  104 , the contents thereof, the source (e.g., physician, pharmacy, drug manufacturer, nutrition center), the end user or consumer (e.g., patient), and the like. The information may be transmitted using any suitable analog and/or digital technique. In various aspects, for example, the single- or multi-dose package  102 ,  104  may transmit information in the form of a packet, e.g., a formatted unit of data consisting of control information and user data (also known as payload). The control information provides data that the local node  106  needs to deliver the user data to the external node  108  such as source and destination addresses, error detection codes like checksums, and sequencing information. Typically, control information is found in packet headers and trailers, with user data in between. In other aspects, the information may be transmitted in a traditional point-to-point communication link to the local node  106  and may simply transmit data as a series of bytes, characters, or bits alone. In other aspects, the information may be transmitted using analog modulation and transmission techniques. 
     The information transmitted by the circuit module  115  may comprise a series of digits representing a suitable identification number such as a serial number, for example, of the single- or multi-dose package  102 ,  104 . In addition, the packet may include information associated with the type of package (single, multiple, morning, afternoon, evening, daily, weekly, monthly dosing event, and so on) the individual patient identification, the date of pre-packaging, the source, and the contents of the package, for example. In some aspects, the expiration date or shelf life of one or all of the medication(s)  112 ,  122  contained in the respective single- or multi-dose packages  102 ,  104  also may be transmitted by the single- or multi-dose packages  102 ,  104 . The information may be communicated with encryption where a secret key may be provided by an entity associated with a remote node  108  such as a physician, pharmacy, drug manufacturer, nutrition center, for example. The IEM device  130 , as discussed in more detail hereinbelow, may be configured to be activated either upon opening the single- or multi-dose package  102 ,  104  or by ingestion by the patient, for example. 
       FIG. 1  illustrates one aspect of a local node  106  in communication with the single- or multi-dose package  102 ,  104  over wireless media  144 ,  146 . In various aspects, the local node  106  may comprise or be implemented by a wireless device. The local node  106  generally may comprise various physical or logical elements implemented as hardware, software, or any combination thereof, as desired for a given set of design parameters or performance constraints. In various aspects, the physical or logical elements may be connected by one or more communications media. For example, communication media may comprise wired communication media, wireless communication media, or a combination of both, as desired for a given implementation. 
     As shown, the local node  106  may comprise an optional display  136 . The display  136  may be implemented using any type of visual interface such as a liquid crystal display (LCD). 
     As shown, the local node  106  may comprise a memory  134 . In various aspects, the memory  134  may comprise any machine-readable or computer-readable media capable of storing data, including both volatile and non-volatile memory. For example, memory may include read-only memory (ROM), random-access memory (RAM), dynamic RAM (DRAM), Double-Data-Rate DRAM (DDR-RAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory (e.g., NOR or NAND flash memory), content addressable memory (CAM), polymer memory (e.g., ferroelectric polymer memory), phase-change memory (e.g., ovonic memory), ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, disk memory (e.g., floppy disk, hard drive, optical disk, magnetic disk), or card (e.g., magnetic card, optical card), or any other type of media suitable for storing information. 
     The local node  106  may comprise a processor  132  such as a central processing unit (CPU). In various aspects, the processor  132  may be implemented as a general purpose processor, a chip multiprocessor (CMP), a dedicated processor, an embedded processor, a digital signal processor (DSP), a network processor, a media processor, an input/output (I/O) processor, a media access control (MAC) processor, a radio baseband processor, a co-processor, a microprocessor such as a complex instruction set computer (CISC) microprocessor, a reduced instruction set computing (RISC) microprocessor, and/or a very long instruction word (VLIW) microprocessor, or other processing device. The processor  510  also may be implemented by a controller, a microcontroller, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a programmable logic device (PLD), and so forth. 
     In various aspects, the processor  132  may be arranged to run an operating system (OS) and various mobile applications. Examples of an OS include, for example, operating systems generally known under the trade name of Microsoft Windows OS, and any other proprietary or open source OS. Examples of mobile applications include, for example, a telephone application, a camera (e.g., digital camera, video camera) application, a browser application, a multimedia player application, a gaming application, a messaging application (e.g., e-mail, short message, multimedia), a viewer application, and so forth. 
     In various aspects, the processor  132  may be arranged to receive information through a communications interface  138 . The communications interface  138  may comprises any suitable hardware, software, or combination of hardware and software that is capable of coupling the local node  106  to one or more networks and/or devices. In one aspect, the local node  106  is in wireless communication with the single-dose package  102  via the wireless medium  144 . The local node  106  also may be in wireless communication with the multi-dose package  104  via the wireless communication medium  146 . The local node  106  may communicate with the remote node  108  via wired communication medium  148  or wireless communication medium  150 . The communications interface  138  may be arranged to operate with any suitable technique for controlling information signals using a desired set of communications protocols, services or operating procedures. The communications interface  138  may include the appropriate physical connectors to connect with a corresponding communications medium, whether wired or wireless. 
     Vehicles of communication include a network. In various aspects, the network may comprise local area networks (LAN) as well as wide area networks (WAN) including without limitation Internet, wired channels, wireless channels, communication devices including telephones, computers, wire, radio, optical or other electromagnetic channels, and combinations thereof, including other devices and/or components capable of/associated with communicating data. For example, the communication environments include in-body communications, various devices, various modes of communications such as wireless communications, wired communications, and combinations of the same. 
     Wireless communication modes include any mode of communication between points that utilizes, at least in part, wireless technology including various protocols and combinations of protocols associated with wireless transmission, data, and devices. The points include, for example, wireless devices such as wireless headsets, audio and multimedia devices and equipment, such as audio players and multimedia players, telephones, including mobile telephones and cordless telephones, and computers and computer-related devices and components, such as printers. 
     Wired communication modes include any mode of communication between points that utilizes wired technology including various protocols and combinations of protocols associated with wired transmission, data, and devices. The points include, for example, devices such as audio and multimedia devices and equipment, such as audio players and multimedia players, telephones, including mobile telephones and cordless telephones, and computers and computer-related devices and components, such as printers. 
     Accordingly, in various aspects, the communications interface  138  may comprise one or more interfaces such as, for example, a wireless communications interface, a wired communications interface, a network interface, a transmit interface, a receive interface, a media interface, a system interface, a component interface, a switching interface, a chip interface, a controller, and so forth. When implemented by a wireless device or within wireless system, for example, the local node  106  may include a wireless interface comprising one or more antennas, transmitters, receivers, transceivers, amplifiers, filters, control logic, and so forth. 
     In various aspects, the local node  106  may provide voice and/or data communications functionality in accordance with different types of cellular radiotelephone systems. In various implementations, the described aspects may communicate over wireless shared media in accordance with a number of wireless protocols. Examples of wireless protocols may include various wireless local area network (WLAN) protocols, including the Institute of Electrical and Electronics Engineers (IEEE) 802.xx series of protocols, such as IEEE 802.11a/b/g/n, IEEE 802.16, IEEE 802.20, and so forth. Other examples of wireless protocols may include various wireless wide area network (WWAN) protocols, such as GSM cellular radiotelephone system protocols with GPRS, CDMA cellular radiotelephone communication systems with 1xRTT, EDGE systems, EV-DO systems, EV-DV systems, HSDPA systems, and so forth. Further examples of wireless protocols may include wireless personal area network (PAN) protocols, such as an Infrared protocol, a protocol from the Bluetooth Special Interest Group (SIG) series of protocols, including Bluetooth Specification versions v1.0, v1.1, v1.2, v2.0, v2.0 with Enhanced Data Rate (EDR), as well as one or more Bluetooth Profiles, and so forth. Yet another example of wireless protocols may include near-field communication techniques and protocols, such as electro-magnetic induction (EMI) techniques. An example of EMI techniques may include passive or active radio-frequency identification (RFID) protocols and devices. Other suitable protocols may include Ultra Wide Band (UWB), Digital Office (DO), Digital Home, Trusted Platform Module (TPM), Zig Bee, and so forth. 
     In various implementations, the described aspects may comprise part of a cellular communication system. Examples of cellular communication systems may include CDMA cellular radiotelephone communication systems, GSM cellular radiotelephone systems, North American Digital Cellular (NADC) cellular radiotelephone systems, Time Division Multiple Access (TDMA) cellular radiotelephone systems, Extended-TDMA (E-TDMA) cellular radiotelephone systems, Narrowband Advanced Mobile Phone Service (NAMPS) cellular radiotelephone systems, third generation (3G) wireless standards systems such as WCDMA, CDMA-2000, UMTS cellular radiotelephone systems compliant with the Third-Generation Partnership Project (3GPP), fourth generation (4G) wireless standards, and so forth. 
     In various aspects, the local node  106  includes the functionality to wirelessly receive and/or wirelessly transmit data received from the single- or multi-dose packages  102 ,  104  and transmit that data to other nodes, such as the external node  108  or other nearby single- or multi-dose packages. 
     Further, in various aspects, the local node  106  may incorporate and/or be associated with, e.g., communicate with, various devices. Such devices may generate, receive, and/or communicate data, e.g., physiologic data. The devices include, for example, “intelligent” devices such as gaming devices, e.g., electronic slot machines, handheld electronic games, electronic components associated with games and recreational activities. 
     The local node  106  may be implemented as a mobile telephone. For example, the local node  106  may be implemented as a short-range, portable electronic device used for mobile voice or data communication over a network of specialized cell site base stations. The mobile telephone is sometimes known as or referred to as “mobile,” “wireless,” “cellular phone,” “cell phone,” or “hand phone (HP),” “smart phone.” 
     In addition to the standard voice function of a telephone, various aspects of mobile telephones may support many additional services and accessories such as short message service (SMS) for text messaging, email, packet switching for access to the Internet, java gaming, wireless, e.g., short range data/voice communications, infrared, camera with video recorder, and multimedia messaging system (MMS) for sending and receiving photos and video. Some aspects of mobile telephones connect to a cellular network of base stations (cell sites), which is, in turn, interconnected to the public switched telephone network (PSTN) or satellite communications in the case of satellite phones. Various aspects of mobile telephones can connect to the Internet, at least a portion of which can be navigated using the mobile telephones. 
     Some embodiments may be implemented, for example, using a machine-readable medium or article which may store an instruction or a set of instructions that, if executed by a machine, may cause the machine to perform a method and/or operations in accordance with the embodiments. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, or the like, and may be implemented using any suitable combination of hardware and/or software. The machine-readable medium or article may include, for example, any suitable type of memory unit, memory device, memory article, memory medium, storage device, storage article, storage medium and/or storage unit, for example, memory, removable or non-removable media, erasable or non-erasable media, writeable or re-writeable media, digital or analog media, hard disk, floppy disk, Compact Disk Read Only Memory (CD-ROM), Compact Disk Recordable (CD-R), Compact Disk Rewriteable (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of Digital Versatile Disk (DVD), a tape, a cassette, or the like. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like. The instructions may be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language, such as C, C++, Java, BASIC, Perl, Matlab, Pascal, Visual BASIC, assembly language, machine code, and so forth. 
     In one aspect, the local node  106  may be configured as a communication hub and may include any hardware device, software, and/or communications component(s), as well as systems, subsystems, and combinations of the same which generally function to communicate information received from the single-dose package  102  and/or the double-dose package  104  to the remote node  108 . Communication of the information includes receiving, storing, manipulating, displaying, processing, and/or transmitting the data to the remote node  108  via wired or wireless media  148 ,  150 . 
     In various aspects, the local node  106  also functions to communicate, e.g., receive and transmit, non-physiologic data. Example of non-physiologic data include gaming rules and data generated by a separate cardiac-related device such as an implanted pacemaker and communicated to the hub directly or indirectly, e.g., via the personal communicator  104 . 
     Broad categories of local nodes  106  include, for example, base stations, personal communication devices, handheld devices, and mobile telephones. In various aspects, the local node  106  may be implemented as a handheld portable device, computer, mobile telephone, sometimes referred to as a smartphone, tablet personal computer (PC), kiosk, desktop computer, or laptop computer, or any combination thereof. Examples of smartphones include, for example, products generally known under the following trade designations Palm, Blackberry, iPhone, Android, Windows Phone, among others. Although some aspects of the external local node  106  may be described with a mobile or fixed computing device implemented as a smart phone, personal digital assistant, laptop, desktop computer by way of example, it may be appreciated that the various aspects are not limited in this context. For example, a mobile computing device may comprise, or be implemented as, any type of wireless device, mobile station, or portable computing device with a self-contained power source, e.g., battery, such as the laptop computer, ultra-laptop computer, personal digital assistant (PDA), cellular telephone, combination cellular telephone/PDA, mobile unit, subscriber station, user terminal, portable computer, handheld computer, palmtop computer, wearable computer, media player, pager, messaging device, data communication device, and so forth. A fixed computing device, for example, may be implemented as a desk top computer, workstation, client/server computer, and so forth. 
     The local node  106  comprises personal communication devices including, for example, devices having communication and computer functionality and typically intended for individual use, e.g., mobile computers, sometimes referred to as “handheld devices.” Base stations comprise any device or appliance capable of receiving data such as physiologic data. Examples include computers, such as desktop computers and laptop computers, and intelligent devices/appliances. Intelligent devices/appliances include consumer and home devices and appliances that are capable of receipt of data such as physiologic data. Intelligent devices/appliances may also perform other data-related functions, e.g., transmit, display, store, and/or process data. Examples of intelligent devices/appliances include refrigerators, weight scales, toilets, televisions, door frame activity monitors, bedside monitors, bed scales. Such devices and appliances may include additional functionality such as sensing or monitoring various physiologic data, e.g., weight, heart rate. Mobile telephones include telephonic communication devices associated with various mobile technologies, e.g., cellular networks. 
     Still with reference to  FIG. 1 , the local node  106  is in communication with the remote node  108 . The remote node  108  comprises a processing system  140  communicatively coupled to a database  142 . Information associated with all patients, including identity and medication types and doses, may be stored in the database  142 . The processing system  140  receives information from the local node  106  and accesses the information in the database  142  of the remote node  108  to provide information to the care provider through the local node  106 . The remote node  108  can communicate information including a photo of the patient for identification, the type of medication available to the care provider, as well as confirmation of the type and dose of medication that the care provider selects and delivers to the patient. The local node  106  can communicate with the remote node  108  using any mode and frequency of communication that is available in at the site, such as wireless, G2, G3, G4, real-time, periodically based on predetermined time delays, as well as store and forward at later time. 
     Vehicles of communication between the local node  106  and the remote node  108  include a network. In various aspects, the network comprises local area networks (LAN) as well as wide area networks (WAN) including without limitation Internet, wired channels, wireless channels, communication devices including telephones, computers, wire, radio, optical or other electromagnetic channels, and combinations thereof, including other devices and/or components capable of/associated with communicating data. For example, the communication environments include in-body communications, various devices, various modes of communications such as wireless communications, wired communications, and combinations of the same. 
     The processing system  140  at the remote node  108  may comprise servers configured as desired, e.g., to provide for subject directed permissions. For example, the servers may be configured to allow a family caregiver to participate in the subject&#39;s therapeutic regimen, e.g., via an interface (such as a web interface) that allows the family caregiver to monitor alerts and trends generated by the server, and provide support back to the patient. The servers also may be configured to provide responses directly to the subject, e.g., in the form of subject alerts, subject incentives, which are relayed to the subject via the communication device. The servers also may interact with a health care professional, e.g., RN, physician, which can use data processing algorithms to obtain measures of health and compliance of the subject, e.g., wellness index summaries, alerts, cross-patient benchmarks, and provide informed clinical communication and support back to the patient. The servers also may interact with pharmacies, nutrition centers, and drug manufactures. 
     In one aspect, the remote node  108  may store in the database  142  the time and date stamp when the single- or double-dose  102 ,  104  packages are opened. In addition, when an IEM device  130  is provided in the dosing unit, the time and date stamp of when the IEM device  130  was ingested by the patient also may be stored in the database  142 . In addition, an identification number such as a serial number, for example, identifying the single- or multi-dose packages  102 ,  104 , the type of package (single, multiple, morning, afternoon, evening, daily, weekly, monthly dosing event, and so on) the individual patient identification, the date of pre-packaging, the source, and the contents of the package, for example, may be stored in the database  142 . In some aspects, the expiration date or shelf life of one or all of the medication(s)  112 ,  122  contained in the respective single- or multi-dose packages  102 ,  104  also may be stored in the database  142 . A specific implementation of the system  100  for tracking a polypharmacy custom medication dosing unit is described hereinbelow in connection with  FIG. 2 . 
       FIG. 2  illustrates one aspect of a system  200  for tracking a polypharmacy custom medication dosing unit and recording a medication event associated therewith. For illustrative purposes, the system shows cross-sectional views of a single-dose package  102  in an open configuration  102 - 1  and a closed configuration  102 - 2 . The single-dose package  102  comprises one or more medications  112  and in some aspects one or more IEM devices  206 . The single-dose package  102  comprises a shell element  103  and a closure element  114 . A circuit element  202  comprising an antenna  204  is associated (e.g., embedded) in the closure element  114 . When the closure element  114  is in a closed configuration, the circuit element  202  is not activated. Although only the single-dose package  102  is disclosed in  FIG. 2  for clarity of disclosure, the same principles apply to the multi-dose package  104  described with reference to  FIG. 1 . Accordingly, the particular aspects of the polypharmacy custom medication dosing unit packages are not limited in the context of the aspects described with reference to  FIG. 2 . 
     When the closure element  114  is peeled off, as shown by the single-dose package  102 - 1 , the circuit element  202  is activated and initiates a wireless transmission using the antenna  204  of the information associated with the single-dose package  102 - 1 . As previously discussed in connection with the description associated with  FIG. 1 , the information comprises the single-dose package  102 - 1  identification number, patient identification information (e.g., name, address, phone number, email, social network web address), dosing unit  112  identification, IEM device  206  identification, time and date stamp when the single-dose package  102 - 1  was opened, time and date stamp when the IEM device was ingested by the patient and activated, among other information. 
     In one aspect, the opened single-dose package  102 - 1  communicates with a local wireless access point  208  (e.g., Wi-Fi), which is coupled to a local area network  210  (LAN). The LAN  210  is coupled to a wide area network such as Internet  224 , which is coupled to the remote node  108 . Accordingly, upon opening the closure element  114  the single-dose package  102 - 1  is able to communicate information to the remote node  108  via the access point  208 , the LAN  210  to hop on the Internet  224 , and to the processing system  140  at the remote node  108  receives the information and stores it for processing by the database  142 . The remote node  108  can access other networks  225  for processing the information received from the single-dose package  102 - 2 . 
     In another aspect, the opened single-dose package  102 - 1  communicates with a one or more mobile devices  216 . The mobile devices  216  may be a handheld portable device, mobile telephone, smartphone, tablet personal computer (PC), or any combination thereof, configured to communicate over a wireless cellular network. The mobile device  216  receives the transmission from the opened single-dose package  102 - 1 . The mobile device  216  communicates with a cell tower  218  and base station  220  and can access the Internet  224  via the cellular network  222 . Accordingly, information received from the opened single-dose package  102 - 2  can be communicated to the remote node  108  via the Internet  224 . The processing system  140  at the remote node  108  receives the information and stores it for processing by the database  142 . 
     In another aspect, when the patient  212  opens the single-dose package  102 - 1  and ingests an IEM device  206 , the IEM device  206  communicates with a patch  214  which includes various electronic modules for receiving a unique signature from the ingested IEM device  206  and communicating with local nodes. It will be appreciated, that in various aspects, the patch  214  may be configured to communicate with the access point  208  as well as the mobile device(s)  216 . It will also be appreciated that the IEM device  206  can communicate with any system, such as the access point  208  or the mobile device  216  prior to ingestion as well as while in the package. Thus the patch  214  can effectively communicate with the remote node  108  via the Internet  224  through the LAN  210  or the cellular network  222 . Substantially concurrently with the ingestion of the IEM device  206 , the opened single-dose package  102 - 1  also initiates communications with either the access point  208  or the mobile device(s)  216  to communicate the information associated with the single-dose package  102 - 1  to the remote node  108 . Software application algorithms resident at any node along the communication path, e.g., another single- or multi-dose package  102 - 1 , the access point  208 , the patch  214 , the mobile device(s)  216 , a server at the base station  220 , a server at the cellular network  222 , the processing system  140 , can correlate the event of ingestion of the IEM device  206  with the patient consuming the other medication(s)  112  contained in the single-dose package  102 - 1 . 
     In other aspects, the opened single-dose package  102 - 1  communicates with a one or more nearby opened or unopened single- or multi-dose packages  102 - 2 . Thus each package can essentially function as a wireless node or relay station. In one aspect, when one package  102 - 1  is opened to take a first dose of medication(s)  112 - 1 , a signal may be transmitted to another package  102 - 2  which contains a second dose of medication(s)  112 - 2  to be consumed by the patient a predetermined later time of the day. For example, when the patient opens the morning (am) single-dose package  102 - 1  to take the morning dose of medication(s)  112 - 1 , a signal may be transmitted to the an afternoon single-dose package  102 - 2  to send a reminder in case the patient  212  to take the afternoon medication(s)  112 - 2 . The signal may be detected by any local nodes such as the access point  208 , the patch  214 , or the mobile device(s)  216 . 
       FIG. 3  illustrates one aspect of a system  300  for packaging and tracking a polypharmacy custom medication dosing unit. The system  300  shown in  FIG. 3  comprises a pharmacy  302  (or physician&#39;s office, drug manufacturer, or nutrition center), a consumer  322 , such as a patient for which the polypharmacy custom medication dosing unit package  304  is produced for, and a remote server computer  324  located at a remote node as described in connection with  FIGS. 1 and 2 . With reference back to  FIG. 3 , the consumer  322  places a request for custom packaged dosing unit package  304  to the remote server computer  324 . The remote server computer  324  receives the request from the consumer  322  and transmits a request to the pharmacy  302  to place an order for the polypharmacy custom medication dosing unit package  304  in accordance with the consumer&#39;s  322  instructions. The pharmacy  302  fills the order and delivers the custom packaged dosing event package  304  to the consumer  322 . Upon receiving the package  304  the consumer  322  takes the medication(s)  112  an/or the IEM device  206  contained in the package  304  in accordance with specific instructions from the physician or pharmacy. When the consumer opens the closure element  114 , the circuit element  202  initiates a wireless transmission via the antenna  204  to a local node, as discussed in connection with  FIGS. 1 and 2 . The dosing event is communicated to the remote server computer  324  via one or more wired and/or wireless networks where the information associated with the consumer, the package  304 , and the date and time stamp of the dosing event, among others, are received by the processing system  326  and stored in a database  328 . The processing system  326  monitors all such dosing events from one or more consumers  322 . The processing system  326  may automatically determine when to place an order for a new supply of polypharmacy custom medication dosing unit package  304  with the pharmacy  302 . 
     It will be appreciated that the remote server computer  324  may be located at a physician&#39;s office, pharmacy, drug manufacturer, nutrition center, or other entity associated with the treatment and prescription of medication(s)  112  and IEM devices  206  to the consumer  322 . In other aspects, the remote server computer  324  may be located in any location worldwide to serve the function of tracking the polypharmacy custom medication dosing unit package  304  consumed by the consumer  322 , placing orders with the pharmacy  302 , among other functions. 
     The polypharmacy custom medication dosing unit package  304  may be produced by the pharmacy  302  or drug manufacturer, physician, nutrition center, or other entity that is qualified to dispense the medication(s)  112  and/or the IEM device  206  contained in the package  304 . Once the pharmacy  302  receives the order for the polypharmacy custom medication dosing unit package  304 , the process of producing such a package  304  may proceed manually, automatically, or a combination of both. As shown, the shell element  103  of the package  102  moves along a computerized conveyer system  320  where the medications that comprise the polypharmacy custom medication dosing unit are dispensed into the shell element  103  from dispensers  306 ,  308 ,  310 ,  312 ,  314 . Each of the dispensers  306 ,  308 ,  310 ,  312 ,  314  releasing a medication into the shell element  103  according to the order received from the remote server  324 . Upon fulfilling the order for the polypharmacy custom medication dosing unit, a closure element comprising a circuit element  202  and antenna  204  is applied to the shell element  103  at station  316 . A printer  318 , or other marking mechanism, applies a custom marking on the exterior portion of the closure element to indicate, among other elements, the name of consumer  322 , the medication(s)  112  content of the package  304 , the IEM device  206  identification, a package  304  identification, date and time that package  304  was filled. Also, the circuit element  202  may be programmed with the information to transmit upon opening the closure element  114 . Such information comprises information associated with the individual consumer (e.g., patient) and/or the medication(s)  112 , the name of the consumer (e.g., patient), packaging date and time, dosing event (e.g., morning, evening, daily), contents of the package, expiration date, shelf life, type of IEM device  206  contained inside the package  304 , for example. 
       FIG. 4A  illustrates one aspect of a single dosing unit customized package  102  for an individual patient where the single dosing unit comprising multiple medications  112 . In the illustrated example, an IEM device  206  also is included in the package  114 . The closure element  114  is shown partially removed from the shell element  103  for the purpose of showing the contents of the package  102 . The exterior portion of the closure element  114  includes the custom printed markings include, without limitation, the name, address, and telephone number of the patient, the contents, the packaging date, and the expiration date. 
       FIG. 4B  is a partial cutaway view of the multiple medication single dosing unit package  102  shown in  FIG. 4A  illustrating a circuit element  202  embedded in the closure element  114  portion of the housing of the multiple medication single dosing unit package  102 . In one aspect, the circuit element  202  comprises a radio circuit and wirelessly transmits information via the antenna  204  when the closure element  114  is peeled off the shell element  103  of the housing. In one aspect, the information transmitted by the circuit element  202  is preprogrammed and may be the same or analogous to the information marked on the exterior portion of the closure element  114 . Although not shown for clarity of disclosure, the multi-dose package  104  shown in  FIG. 1 , also comprises a similar circuit module  115  embedded in the individual closure element  118 . 
       FIG. 5A  is a diagram illustrating a typical packet  500  of information communicated from an individual patient customized single-dose package. In one aspect, the packet  500  includes the patient&#39;s name, address and telephone number, the package identification, the contents of the package including IEM device identification is applicable, the dosing event (e.g., AM/PM), the date and time when the package was sealed, the date and time when the package was opened, and the expiration date of the contents of the package. 
       FIG. 5B  is a diagram illustrating a typical packet  550  of information communicated from an individual patient customized multi-dose package. In one aspect, the packet  550  includes the information included in the packet  500  shown in  FIG. 5A  and in addition includes the day of the week corresponding to the opened compartment from which the medication was taken. 
       FIG. 6  is a block functional diagram of one aspect of an integrated circuit component of the patch  214  shown in  FIG. 2 . In  FIG. 6 , a patch  600  comprises an electrode input  610 . Electrically coupled to the electrode input  610  are a transbody conductive communication module  620  and a physiological sensing module  630 . In one aspect, the transbody conductive communication module  620  is implemented as a first, e.g., high, frequency (HF) signal chain and the physiological sensing module  630  is implemented as a second, e.g., low, frequency (LF) signal chain. Also shown are CMOS temperature sensing module  640  (for detecting ambient temperature) and a 3-axis accelerometer  650 . The patch  600  also comprises a processing engine  660  (for example, a microcontroller and digital signal processor), a non-volatile memory  670  (for data storage), and a wireless communication module  680  (to receive data from and/or transmit data to another device, for example in a data download/upload action, respectively). In various aspects, the communication modules  620 ,  680  may comprise one or more transmitters/receivers (“transceiver”) modules. As used herein, the term “transceiver” may be used in a very general sense to include a transmitter, a receiver, or a combination of both, without limitation. In one aspect, the transbody conductive communication module  620  is configured to communicate with the IEM device  206 - 1  ( FIG. 2 ). In one aspect, the wireless communication module  680  may be configured to communicate with the wireless access point  208  ( FIG. 2 ). In another aspect, the wireless communication module  680  may be configured to communicate with the opened single-dose package  102 - 1  ( FIG. 2 ), or multi-dose package, for example. In yet another aspect, the wireless communication module  680  may be configured to communicate with the mobile devices  216  ( FIG. 2 ). 
     The sensors  616  typically contact the patient  212  ( FIG. 2 ), e.g., are removably attached to the torso. In various aspects, the sensors  616  may be removably or permanently attached to the patch  600 . For example, the sensors  616  may be removably connected to the patch  600  by snapping metal studs. The sensors  616  may comprise, for example, various devices capable of sensing or receiving the physiologic data. The types of sensors  616  include, for example, electrodes such as biocompatible electrodes. The sensors  616  may be configured, for example, as a pressure sensor, a motion sensor, an accelerometer, an electromyography (EMG) sensor, an IEM device  206  ( FIG. 2 ), a biopotential sensor, an electrocardiogram sensor, a temperature sensor, a tactile event marker sensor, and an impedance sensor. 
     The feedback module  618  may be implemented with software, hardware, circuitry, various devices, and combinations thereof. The function of the feedback module  618  is to provide communication with the patient  212  ( FIG. 2 ) in a discreet, tactful, circumspect manner as described above. In various aspects the feedback module  618  may be implemented to communicate with the patient  212  using techniques that employ visual, audio, vibratory/tactile, olfactory, and taste. 
       FIG. 7  shows one aspect of an ingestible event marker. In various aspects the IEM devices  130 ,  206  shown in FIGS.  1  and  2 - 4  may be implemented in accordance with the system  720  shown in  FIG. 7 . The system  720  can be used in association with any medication product, as mentioned above, to determine the origin of the medication and to confirm that at least one of the right type and the right dosage of medication was delivered to the patient and in some aspects to determine when a patient takes the medication product. The scope of the present disclosure, however, is not limited by the environment and the medication product that may be used with the system  720 . For example, the system  720  may be activated either in wireless mode, in galvanic mode by placing the system  720  within a capsule and then placing the capsule within a conducting fluid, or a combination thereof, or exposing the system  720  to air. Once placed in a conducting fluid, for example, the capsule would dissolve over a period of time and release the system  720  into the conducting fluid. Thus, in one aspect, the capsule would contain the system  720  and no product. Such a capsule may then be used in any environment where a conducting fluid is present and with any product. For example, the capsule may be dropped into a container filled with jet fuel, salt water, tomato sauce, motor oil, or any similar product. Additionally, the capsule containing the system  720  may be ingested at the same time that any pharmaceutical product is ingested in order to record the occurrence of the event, such as when the product was taken. 
     In the specific example of the system  720  combined with a medication or pharmaceutical product, as the product or pill is ingested, or exposed to air, the system  720  is activated in galvanic mode. This may be particularly useful when a caregiver or user wants to know if the seal of the ingestible device has been broken on the single- or multi-dose packages  102 ,  104  ( FIGS. 1-4 ), or if the ingestible device was exposed to air in certain climates, e.g., high humidity that may potentially degrade an ingestible device such as an IEM device  130  ( FIG. 1 ),  206  ( FIGS. 2-4 ). The system  720  controls conductance to produce a unique current signature that is detected by the patch  214  ( FIG. 2 ), for example, thereby signifying that the pharmaceutical product has been taken. When activated in wireless mode, the system controls modulation of capacitive plates to produce a unique voltage signature associated with the system  720  that is detected. 
     In one aspect, the system  720  includes a framework  722 . The framework  722  is a chassis for the system  720  and multiple components are attached to, deposited upon, or secured to the framework  722 . In this aspect of the system  720 , a digestible material  724  is physically associated with the framework  722 . The material  724  may be chemically deposited on, evaporated onto, secured to, or built-up on the framework all of which may be referred to herein as “deposit” with respect to the framework  722 . The material  724  is deposited on one side of the framework  722 . The materials of interest that can be used as material  724  include, but are not limited to: Cu, CuCI, or Cul. The material  724  is deposited by physical vapor deposition, electrodeposition, or plasma deposition, among other protocols. The material  724  may be from about 0.05 to about 500 μm thick, such as from about 5 to about 100 μm thick. The shape is controlled by shadow mask deposition, or photolithography and etching. Additionally, even though only one region is shown for depositing the material, each system  720  may contain two or more electrically unique regions where the material  724  may be deposited, as desired. 
     At a different side, which is the opposite side as shown in  FIG. 7 , another digestible material  726  is deposited, such that the materials  724 ,  726  are dissimilar and insulated from each other. Although not shown, the different side selected may be the side next to the side selected for the material  724 . The scope of the present disclosure is not limited by the side selected and the term “different side” can mean any of the multiple sides that are different from the first selected side. In various aspects, the dissimilar material may be located at different positions on a same side. Furthermore, although the shape of the system is shown as a square, the shape may be any geometrically suitable shape. The materials  724 ,  726  are selected such that they produce a voltage potential difference when the system  720  is in contact with conducting liquid, such as body fluids. The materials of interest for material  726  include, but are not limited to: Mg, Zn, or other electronegative metals. As indicated above with respect to the material  724 , the material  726  may be chemically deposited on, evaporated onto, secured to, or built-up on the framework. Also, an adhesion layer may be necessary to help the material  726  (as well as material  724  when needed) to adhere to the framework  722 . Typical adhesion layers for the material  726  are Ti, TiW, Cr or similar material. Anode material and the adhesion layer may be deposited by physical vapor deposition, electrodeposition or plasma deposition. The material  726  may be from about 0.05 to about 500 μm thick, such as from about 5 to about 100 μm thick. However, the scope of the present disclosure is not limited by the thickness of any of the materials nor by the type of process used to deposit or secure the materials to the framework  722 . 
     According to the disclosure set forth, the materials  724 ,  726  can be any pair of materials with different electrochemical potentials. Additionally, in the embodiments wherein the system  720  is used in-vivo, the materials  724 ,  726  may be vitamins that can be absorbed. More specifically, the materials  724 ,  726  can be made of any two materials appropriate for the environment in which the system  720  will be operating. For example, when used with an ingestible product, the materials  724 ,  726  are any pair of materials with different electrochemical potentials that are ingestible. An illustrative example includes the instance when the system  720  is in contact with an ionic solution, such as stomach acids. Suitable materials are not restricted to metals, and in certain embodiments the paired materials are chosen from metals and non-metals, e.g., a pair made up of a metal (such as Mg) and a salt (such as CuCI or Cul). With respect to the active electrode materials, any pairing of substances—metals, salts, or intercalation compounds—with suitably different electrochemical potentials (voltage) and low interfacial resistance are suitable. 
     Materials and pairings of interest include, but are not limited to, those reported in TABLE 1 below. In one embodiment, one or both of the metals may be doped with a non-metal, e.g., to enhance the voltage potential created between the materials as they come into contact with a conducting liquid. Non-metals that may be used as doping agents in certain embodiments include, but are not limited to: sulfur, iodine, and the like. In another embodiment, the materials are copper iodine (Cul) as the anode and magnesium (Mg) as the cathode. Aspects of the present disclosure use electrode materials that are not harmful to the human body. 
     
       
         
           
               
               
               
             
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Anode 
                 Cathode 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Metals 
                 Magnesium, Zinc 
                   
               
               
                   
                 Sodium, Lithium 
               
               
                   
                 Iron 
               
               
                 Salts 
                   
                 Copper salts: iodide, chloride, bromide, 
               
               
                   
                   
                 sulfate, formate, (other anions possible) 
               
               
                   
                   
                 Fe 3+  salts: e.g. orthophosphate, 
               
               
                   
                   
                 pyrophosphate, (other anions possible) 
               
               
                   
                   
                 Oxygen or Hydrogen ion (H+) on 
               
               
                   
                   
                 platinum, gold or other catalytic 
               
               
                   
                   
                 surfaces 
               
               
                 Intercalation 
                 Graphite with Li, 
                 Vanadium oxide 
               
               
                 compounds 
                 K, Ca, Na, Mg 
                 Manganese oxide 
               
               
                   
               
            
           
         
       
     
     Thus, when the system  720  is in contact with the conducting fluid, a current path is formed through the conducting fluid between the dissimilar materials  724 ,  726 . A control device  728  is secured to the framework  722  and electrically coupled to the materials  724 ,  726 . The control device  728  includes electronic circuitry, for example control logic that is capable of controlling and altering the conductance between the materials  724 ,  726 . 
     The voltage potential created between the dissimilar materials  724 ,  726  provides the power for operating the system as well as produces the current flow through the conducting fluid and the system  720 . In one aspect, the system  720  operates in direct current mode. In an alternative aspect, the system  720  controls the direction of the current so that the direction of current is reversed in a cyclic manner, similar to alternating current. As the system reaches the conducting fluid or the electrolyte, where the fluid or electrolyte component is provided by a physiological fluid, e.g., stomach acid, the path for current flow between the dissimilar materials  724 ,  726  is completed external to the system  720 ; the current path through the system  720  is controlled by the control device  728 . Completion of the current path allows for the current to flow and in turn a receiver, not shown, can detect the presence of the current and recognize that the system  720  has been activate and the desired event is occurring or has occurred. 
     In one aspect, the two materials  724 ,  726  are similar in function to the two electrodes needed for a direct current power source, such as a battery. The conducting liquid acts as the electrolyte needed to complete the power source. The completed power source described is defined by the electrochemical reaction between the materials  724 ,  726  of the system  720  and enabled by the fluids of the body. The completed power source may be viewed as a power source that exploits electrochemical conduction in an ionic or a conducting solution such as gastric fluid, blood, or other bodily fluids and some tissues. 
     Additionally, the environment may be something other than a body and the liquid may be any conducting liquid. For example, the conducting fluid may be salt water or a metallic based paint. 
     In certain aspects, the two dissimilar materials  724 ,  726  are shielded from the surrounding environment by an additional layer of material. Accordingly, when the shield is dissolved and the two dissimilar materials  724 ,  726  are exposed to the target site, a voltage potential is generated. 
     In certain aspects, the complete power source or supply is one that is made up of active electrode materials, electrolytes, and inactive materials, such as current collectors, packaging. The active materials are any pair of materials with different electrochemical potentials. Suitable materials are not restricted to metals, and in certain embodiments the paired materials are chosen from metals and non-metals, e.g., a pair made up of a metal (such as Mg) and a salt (such as Cul). With respect to the active electrode materials, any pairing of substances—metals, salts, or intercalation compounds—with suitably different electrochemical potentials (voltage) and low interfacial resistance are suitable. 
     A variety of different materials may be employed as the materials that form the electrodes. In certain embodiments, electrode materials are chosen to provide for a voltage upon contact with the target physiological site, e.g., the stomach, sufficient to drive the system of the identifier. In certain embodiments, the voltage provided by the electrode materials upon contact of the metals of the power source with the target physiological site is 0.001 V or higher, including 0.01 V or higher, such as 0.1 V or higher, e.g., 0.3 V or higher, including 0.5 volts or higher, and including 1.0 volts or higher, where in certain embodiments, the voltage ranges from about 0.001 to about 10 volts, such as from about 0.01 to about 10 V. 
     Referring still to  FIG. 7 , the dissimilar materials  724 ,  726  provide the voltage potential to activate the control device  728 . Once the control device  728  is activated or powered up, the control device  728  can alter conductance between the first and second materials  724 ,  726  in a unique manner. By altering the conductance between the first and second materials  724 ,  726 , the control device  728  is capable of controlling the magnitude of the current through the conducting liquid that surrounds the system  720 . This produces a unique current signature that can be detected and measured by a receiver (not shown), which can be positioned internal or external to the body. The receiver is disclosed in greater detail in U.S. patent application Ser. No. 12/673,326 entitled “BODY-ASSOCIATED RECEIVER AND METHOD” filed on Dec. 15, 2009, and published as 2010-0312188 A1 dated Dec. 9, 2010, which is incorporated herein by reference in its entirety. In addition to controlling the magnitude of the current path between the materials, non-conducting materials, membrane, or “skirt” are used to increase the “length” of the current path and, hence, act to boost the conductance path, as disclosed in the U.S. patent application Ser. No. 12/238,345 entitled, “IN-BODY DEVICE WITH VIRTUAL DIPOLE SIGNAL AMPLIFICATION” filed Sep. 25, 2008, and published as 2009-0082645 A1 dated Mar. 26, 2009 the entire content of which is incorporated herein by reference. Alternatively, throughout the disclosure herein, the terms “non-conducting material,” “membrane,” and “skirt” are interchangeably used with the term “current path extender” without impacting the scope or the present embodiments and the claims herein. The skirt, shown in portion at  725 ,  727 , respectively, may be associated with, e.g., secured to, the framework  722 . Various shapes and configurations for the skirt are contemplated as within the scope of the various aspects of the present invention. For example, the system  720  may be surrounded entirely or partially by the skirt and the skirt may be positioned along a central axis of the system  120  or off-center relative to a central axis. Thus, the scope of the present invention as claimed herein is not limited by the shape or size of the skirt. Furthermore, in other embodiments, the dissimilar materials  724 ,  726  may be separated by one skirt that is positioned in any defined region between the dissimilar materials  724 ,  726 . 
     The system  720  may be grounded through a ground contact. The system  720  also may include a sensor module. In operation, ion or current paths are established between the first material  724  to the second material  726  and through a conducting fluid in contact with the system  720 . The voltage potential created between the first and second materials  724 ,  726  is created through chemical reactions between the first and second materials  724 ,  726  and the conducting fluid. In one aspect, the surface of the first material  724  is not planar, but rather an irregular surface. The irregular surface increases the surface area of the material and, hence, the area that comes in contact with the conducting fluid. 
     In one aspect, at the surface of the first material  724 , there is chemical reaction between the material  724  and the surrounding conducting fluid such that mass is released into the conducting fluid. The term mass as used herein refers to protons and neutrons that form a substance. One example includes the instant where the material is CuCl and when in contact with the conducting fluid, CuCl becomes Cu (solid) and Cl— in solution. The flow of ions into the conduction fluid is via ion paths. In a similar manner, there is a chemical reaction between the second material  726  and the surrounding conducting fluid and ions are captured by the second material  726 . The release of ions at the first material  724  and capture of ion by the second material  726  is collectively referred to as the ionic exchange. The rate of ionic exchange and, hence the ionic emission rate or flow, is controlled by the control device  728 . The control device  728  can increase or decrease the rate of ion flow by altering the conductance, which alters the impedance, between the first and second materials  724 ,  726 . Through controlling the ion exchange, the system  720  can encode information in the ionic exchange process. Thus, the system  720  uses ionic emission to encode information in the ionic exchange. 
     The control device  728  can vary the duration of a fixed ionic exchange rate or current flow magnitude while keeping the rate or magnitude near constant, similar to when the frequency is modulated and the amplitude is constant. Also, the control device  728  can vary the level of the ionic exchange rate or the magnitude of the current flow while keeping the duration near constant. Thus, using various combinations of changes in duration and altering the rate or magnitude, the control device  728  encodes information in the current flow or the ionic exchange. For example, the control device  728  may use, but is not limited to any of the following techniques namely, Binary Phase-Shift Keying (PSK), Frequency Modulation (FM), Amplitude Modulation (AM), On-Off Keying, and PSK with On-Off Keying. 
     Various aspects of the system  720  may comprise electronic components as part of the control device  728 . Components that may be present include but are not limited to: logic and/or memory elements, an integrated circuit, an inductor, a resistor, and sensors for measuring various parameters. Each component may be secured to the framework and/or to another component. The components on the surface of the support may be laid out in any convenient configuration. Where two or more components are present on the surface of the solid support, interconnects may be provided. 
     The system  720  controls the conductance between the dissimilar materials and, hence, the rate of ionic exchange or the current flow. Through altering the conductance in a specific manner the system is capable of encoding information in the ionic exchange and the current signature. The ionic exchange or the current signature is used to uniquely identify the specific system. Additionally, the system  720  is capable of producing various different unique exchanges or signatures and, thus, provides additional information. For example, a second current signature based on a second conductance alteration pattern may be used to provide additional information, which information may be related to the physical environment. To further illustrate, a first current signature may be a very low current state that maintains an oscillator on the chip and a second current signature may be a current state at least a factor of ten higher than the current state associated with the first current signature. 
     It is worthy to note that any reference to “one aspect” or “an aspect” means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, appearances of the phrases “in one aspect” or “in an aspect” in various places throughout the specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects. 
     Some aspects may be described using the expression “coupled” and “connected” along with their derivatives. It should be understood that these terms are not intended as synonyms for each other. For example, some aspects may be described using the term “connected” to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact. The term “coupled,” however, also may mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. 
     While certain features of the aspects have been illustrated as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the aspects.