Patent Publication Number: US-2021161769-A1

Title: Smart Pack System for Medicines

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This Application is a continuation application of U.S. patent application Ser. No. 15/621,842, filed on Jun. 13, 2017, now U.S. Pat. No. ______; which in turn claims priority to U.S. Provisional Application No. 62/351,954, filed on Jun. 18, 2016. Each of the foregoing applications is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Medicines have played an important role in the health and welfare of people throughout the world. Medicines have cured diseases, prevented infections from spreading, and reduced the instances of serious health problems. Prescription pharmaceuticals have been especially important in preventing, treating, and curing diseases. 
     SUMMARY 
     An embodiment of the present invention may therefore comprise a packet for dispensing solid medications comprising: a blister pack having a plurality of blister pockets that contain said medication; an overlay that is attached to said blister pack; geometric pattern conductors disposed on said overlay and aligned with said blister pockets when that overlay is attached to said blister pack so that said geometric pattern conductors are broken when said medication is removed from said blister pockets creating open circuits in said geometric pattern conductors; a plurality of connecting conductors disposed on said overlay that are connected to said geometric pattern conductors in a manner that provides sufficient information to detect said open circuits in said geometric pattern conductors and identify said geometric pattern conductors that have been broken; processing and storage circuitry disposed on said plastic overlay that detect said open circuits and store a time when said open circuit is detected, to create adherence data. 
     An embodiment of the present invention may further comprise a method of packaging solid medication in a packet and collecting adherence data indicating patient adherence to a medication schedule comprising: filling blister pockets in a blister pack with said solid medication; placing geometric pattern conductors on an overlay that are aligned with said blister pockets when said overlay is attached to said blister pack; placing a plurality of connecting conductors on said overlay that are connected to said geometric pattern conductors so that said geometric pattern conductors that have been broken can be identified; placing said overlay on said blister pack, said overlay having electronics and communication circuitry; and using said electronics and communication circuitry to detect when said geometric pattern conductors are broken by checking conductance of said connecting inductors; storing a time and date when said geometric pattern conductors are broken, to create said adherence data. 
     An embodiment of the present invention may further comprise an automated dispenser that dispenses medications to a user comprising: a package containing medications comprising: a blister package containing said medication in blister pockets; processing, storage, and communication circuitry disposed on an overlay that covers said blister pockets, said processing storage, and communication circuitry containing identifying said medication; communication electronics disposed in said automated dispenser that receives prescriptions for said medication and receives said data identifying said medication from said processing, storage and communication circuitry disposed on said overlay; a processor that generates control signals that control a card reader that reads debit and credit cards, a display screen to prompt said user, a labeler that generates a label containing information identifying a patient taking said medication and instructions for taking said medication, and a dispenser that dispenses said medication. 
     An embodiment of the present invention may further comprise a method of automatically dispensing medication to an authorized user of an automated dispenser comprising: packaging said medication in a blister package having processing, storage and communication circuitry disposed on an overlay of said blister package that contains data that identifies said medication packaged in said blister package; communicating said data identifying said medication from said blister package to said automated dispenser; receiving prescription data for a patient at said automated dispenser; programming said blister package with said prescription data; generating a patient label identifying said patient for said medication and instructions for use of said medication; applying said patient label to said blister package; verifying that a user of said automated dispenser is said authorization user of said automated dispenser; dispensing said medication to said authorized user. 
     An embodiment of the present invention may further comprise a communication system that communicates adherence data, indicating adherence by a patient to a medication schedule, for access by authorized individuals on a network comprising: a smart dispensing package comprising: a blister pack having a plurality of blister pockets that contain medication; a plastic overlay that is attached to said blister pack; a plurality of geometric pattern conductors disposed on said plastic overlay that are aligned with said blister pockets when said overlay is attached to said blister pack do that said geometric pattern conductors are broken when said medication is removed from said blister pockets, creating an open circuit; a plurality of connecting conductors disposed on said overlay that are connected to said geometric pattern conductors in a manner that provides sufficient information to detect an open circuit in each of said geometric pattern conductors so that open circuits in each of said geometric pattern conducts can be identified; processing and storage circuitry disposed in said plastic overlay that detects said open circuits and stores a time when said open circuit is detected, to create adherence data; communication circuitry disposed on said plastic overlay and connected to said processing and storage circuitry that transmits said adherence data on an antenna disposed in said plastic overlay; a handheld communicator that receives said adherence data from said smart dispensing package and transmits said adherence data to a network for storage and access by said authorized individuals. 
     An embodiment of the present invention may further comprise a method of transmitting adherence data from a packet that contains solid medications comprising: packaging said medication in blister pockets of a blister package; detecting an opening of a blister pocket by detecting conductance of a plurality of conductors disposed on an overlay that cover said blister pockets; recording a time when said blister pocket is opened to create adherence data; transmitting said adherence data from said packet to a handheld communicator; transmitting said adherence data from said handheld communicator to a network that is accessible by authorized individuals. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic block diagram of an embodiment of a blister pack smart dispensing package (smart pack). 
         FIG. 2  is a detailed view of an embodiment of a smart dispensing package. 
         FIG. 3  is a schematic block diagram of the data transfer structure for the smart pack system. 
         FIG. 4  is a flow diagram of the distribution and data collection process for an embodiment of a smart pack system. 
         FIG. 5  is an illustration of an embodiment of a smart pack package for the smart pack system. 
         FIG. 6  is a schematic illustration of an embodiment of an automated smart pack dispenser. 
         FIG. 7  is a block diagram of an embodiment of the electronics structure of an automated smart pack dispenser. 
         FIGS. 8-10  are schematic illustrations of an embodiment of a smart pack that changes colors or shades as the medications in the smart pack approach expiration and reach expiration. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       FIG. 1  is a schematic block diagram of an embodiment of a blister pack smart dispensing package  100  that is referred to herein as a “smart pack  100 .” As disclosed in  FIG. 1 , the smart pack  100  consists of a blister pack  104  that has a plurality of indentations or blister pockets  110  that are arranged and sized to carry solid medications, such as one or more pills, gummies, etc., referred to herein as “pills.” The pills may be prescription or non-prescription medications, supplements, or other substances that may be desirable to ingest on a periodic basis. For example, vitamin or mineral supplements can be used with the smart pack  100 , illustrated in  FIG. 1 . The blister pack  104  can be fabricated from any standard material that meets FDA regulations for materials suitable for use with pills including many plastics and is capable of deformation to form the blister pockets  110 . 
     As also illustrated in  FIG. 1 , the blister overlay  102  has the same form and size as the blister pack  104 . The blister overlay  102  may have a contact adhesive coating on a lower surface, so that when the blister overlay  102  is placed on the blister pack  104 , it becomes secured to the blister pack  104 . Other standard methods of securing the blister overlay  102  to the blister pack  104  can be used, such as a UV sealing, a heat responsive adhesive, or other adhesives. The electronics and communications package  122  is located over a portion of the blister pack  104  that does not have blister pockets  110 , such as illustrated in the embodiment shown in  FIG. 2 . The conductors  106  are laid out over the area where the blister pockets  110  are disposed, as also shown in  FIG. 2 . 
     Referring again to  FIG. 1 , the electronics and communication package  122  includes a processor  108  that is connected to the conductors  106 . The processor  108  transmits signals periodically to the conductors  106  to determine conductivity and thereby determine if a portion of the blister overlay  102  has been punctured to remove a pill disposed in a blister pocket  110 . When it is determined that there is a lack of conductivity (open circuit) of the conductors adjacent to a blister pocket  110 , indicating that a pill has been removed from a blister pocket  110 , the time and date is stored in storage circuitry  120 . The processor  108  then transmits this information (referred to herein as “adherence data”) to the communications circuitry  112 , which causes the adherence data to be transmitted via antenna  114 , to a local receiver. In one embodiment, a mobile phone, pad computer, or other device, connects with the electronics and communication package using a near field communication (NFC) signal when a link is established. The communications circuitry  112  requests adherence data from processor  108 , which then retrieves the adherence data from storage  120 . The adherence data indicates whether a patient has adhered to the medication schedule that has been prescribed for that medication. The processor  108  then transmits the adherence data retrieved from storage  120  to the communications packet  112  and to the antenna  114 . The adherence data is then received by the NFC device, or other communication device, such as a mobile phone, as explained in more detail below. A battery  105  powers the electronics and communicator package  122 . A GPS receiver  107  may also be included in the electronics and communications package  122 . GPS receiver  107  is connected to antenna  114  and receives satellite data, determines a physical location of the smart pack  100  and transmits the location data to processor  108 . 
       FIG. 2  is a schematic illustration of the smart dispensing packet  100  showing the conductors  106  that are disposed on the blister overlay  102 . The conductors may be deposited on the blister overlay  102  using a conductive ink, or other conductive material. As illustrated in  FIG. 2 , the conductors  106  are spread out in a geometric pattern, creating geometric pattern conductors  115  that are positioned over the puncture area  116  of the blister overlay, so that puncture of the blister overlay  102  to retrieve medication from a blister pocket  110  ( FIG. 1 ) will result in the geometric pattern conductor  115  being broken and disconnected from the circuit, creating an open circuit. The lack of a conductive path for that particular row and column for the blister pocket  110 , where the open current is located, is determined by the electronics and communication circuitry  122 , and the time and day, and in some cases the location of the smart pack  100 , is recorded by the electronics and communication circuitry  122 . When there is a puncture and a resultant open circuit, it is assumed that the patient punctured the blister overlay  102 , removed, and consumed the medication. The time and day and in some cases the location that this occurred is referred to as “adherence data” since the data indicates whether the patient has adhered to the prescribed medication schedule. This adherence data is stored in the electronics and communication circuitry  122 . The blister overlay  102  is made from a thin plastic material, which allows a user to puncture the blister overlay  102  to gain access to the pills stored in a blister pocket  110 . The blister overlay  102  is, however, sufficiently strong to prevent accidental puncture and disruption of the conductors  106  on the blister overlay  102 . Conductive ink, which forms a conductor, can be applied in several different ways. For example, conductive ink can be screened onto the blister overlay  102 , using standard off-set printing techniques or standard screening techniques. In addition, the conductive ink can be applied with a plotter using inkjet technology. Other methods can also be used. It is important that the ink adhere well to the blister overlay  102 , so that a material should be used for the blister overlay  102  that allows for good adhesion of the conductive ink. The overlay materials may be foil materials that are coated with an insulated plastic, a paper material, various plastics, biodegradable materials, plant based materials that change color over time such as disclosed herein, heat sensitive materials, UV sensitive materials, linear or bidirectional aligned molecular material or virtually any material that can be printed and broken using standard finger pressure. Single or multiple layer overlay configurations consisting of either a single or multiple materials can also be used. Printed electronics can be used in multiple layer configurations to prevent the accidental removal of a conductor as a result of abrasion during handling of the smart pack  100 . The materials used should be designed to have a selective bursting pressure which allows a user to access a blister pocket  110  using standard finger pressure. In addition, the overlay may have reinforced areas that are not aligned with the blister pockets  110  so that the bursting pressure adjacent the blister pockets  110  is much less than other portions of the blister overlay  102 . Polypropylene and polyethylene are two example materials that may be used for the blister overlay  102 . The conductive ink can be made from various materials including powder, liquid or plant based materials. The conductive ink can be curable with heat, UV light or various chemical processes. The conductive ink can also cure simply by drying. The conductive ink is flexible and has the ability to conduct when subjected to fluctuations such as bending of the blister overlay  102 . The conductive ink can be formulated to change color or shades upon the occurrence of certain conditions. For example, the conductive ink may initially be invisible to minimize the visual footprint of the printed electronics while retaining the conductive functionality of the conductive ink. A color change or shading change may then occur to indicate a change of state or environmental change such as when the package contents have expired. For example, the conductive ink or other inks placed on the overlay can indicate that the package contents, i.e. the medications or other materials stored in the blister pack, have expired. 
     The conductors  106  may comprise geometric pattern conductors  115  such as the zigzag geometric pattern conductors illustrated in  FIG. 2 . Of course, any geometric pattern can be used for the geometric pattern conductor  115 . The conductors  106  also include the connecting conductors  117  that connect the geometric pattern conductors  115  to the electronics and communication circuitry  122 . The connecting conductors  117  may be laid out in rows and columns or other layout that allows identification of each geometric pattern conductor  115  that is broken. In other words, the connecting conductors  117  are connected to the geometric pattern conductors  115  in a manner that allows each of the geometric pattern conductors  115  to be individually identified as to the location of the geometric pattern conductor  115  on the blister overlay  102  so that the blister pocket  110  that has been accessed can be identified using conductance to identify the rows and columns of each geometric pattern conductor  115 , that has been broken. The use of series connected resistive conductors to reduce the number of connecting conductors, such as disclosed in U.S. Pat. No. 8,960,440 and U.S. patent application publications US 2015/0286852, US 2015/0148947, US 2010/0089791, US 2017/004284 and PCT application WO 2017/062464 does not allow identification of individual blister pockets such as blister pocket  110 . The identification of which blister pocket has been opened allows identification of the medication that has been accessed by the patient. In this manner, there is no confusion as to the specific blister pocket that has been opened or number of blister pockets  110  that have been accessed, and the specific date and time which these blister pockets have been accessed. As such, a clear chain of possession of each of the pills of the medication can be established. 
     In addition, the electronics in communication package  122  which is placed on the blister overlay  102  is operated by battery  105 . Using resistive elements to determine which blister pocket has been accessed uses substantially more energy than simply checking the conductance of the conductors  106 . Accordingly, the layout, such as illustrated in  FIG. 2  in which each geometric pattern conductor  115  can be checked for conductance because each geometric pattern conductor  115  is connected to a connecting conductor  117  is a much more efficient manner of determining the location of a broken geometric pattern conductor  115  compared to using resistive elements. 
     Furthermore, both the geometric pattern conductors  115  and the connecting conductors  117  can be easily and inexpensively printed with conductive ink as described above. The inexpensive processes for printing the conductive ink such as screening, ink jet printing, off-set printing and the other techniques described as well as other inexpensive techniques reduces the manufacturing costs of the smart dispensing package  100 . The smart dispensing package  100  then becomes a disposable package that is manufactured by highly automated techniques to allow mass-production of the smart dispensing package  100 . The electronics and communications circuitry  122  can be attached to the blister overlay  102  using adhesives or other bonding materials that firmly secure the electronics and communications circuitry  122  to the overlay  102 . Automated pick-and-place robots can accurately place the electronics and communication circuitry  122  on the blister overlay  102 . In addition, the conductors  106  can be accurately aligned with the electronics and communications circuitry  102  using standard edge detection techniques. Electronics and communications circuitry  122  includes an antenna  114  ( FIG. 1 ) for transmitting and receiving information on the blister pack smart dispensing package  100 . The antenna can be printed using conductive ink using the various techniques disclosed herein. 
       FIG. 3  is a schematic block diagram illustrating an embodiment of a system for data transfer of data generated by the smart dispensing package  302 . As illustrated in  FIG. 3 , the smart pack, or smart dispensing package  302 , collects and stores adherence data, together with information regarding the patient as described above. A handheld device, such as a cell phone, pad computer, or other device, that includes a communications system, links to the smart dispensing package  302 . When a communication link is established, the smart dispensing package  302  retrieves adherence data and medical identification data for the patient from storage  120  ( FIG. 1 ) and transmits the adherence data via communications package  112  and antenna  114  to the handheld device  304 . 
     The handheld device  304  of  FIG. 3  can comprise any device that can establish a link to smart pack  302  and retransmit data, and does not have to be handheld. For example, fixed communications systems may be located at various locations, such as in homes, public buildings, malls, doctors&#39; offices, hospitals, and other locations that can perform the same functions as the handheld device  304  and, for purposes of this application are all referred to as handheld devices. The handheld device  304  may use any number of different protocols, including a near field communication protocol, Bluetooth, Wifi, various RFID protocols, zigbee, WIMAX, or other communication protocol. For ease of disclosure, all of these communication devices are referred to hereinafter as “handheld devices” even if they are stationary devices. 
     The handheld device of  FIG. 3  then retransmits the adherence data to the cloud  305 . The cloud  305  consists of servers and storage for storing adherence data for each patient, which can then be accessed, via a secure password, or other security techniques such as by encryption, by authorized individuals, such as law enforcement  308 , healthcare providers  310 , pharmacies  312 , or insurance companies  314 . The adherence data can be used to create a patient accountability score or adherence score which can be used for a number of different purposes. Patient accountability data is used to create an accountability score, or patient accountability, that indicates how accountable a patient has been in adhering to the regimen of taking the medication. An accountability score can be generated in various different ways. For example, a patient accountability score can be generated based upon the percentage of the times which the patient has taken the medication. As an example, if a patient is only taking the medication 50% of the time, the patient score can be 50. If the patient takes the medication 100% of the time, the score would be 100. The scoring entity can also modify the score if the patient takes the medication late. In this manner, a patient accountability score can be created in accordance with the specific information that is of importance to the entity that designs the patient accountability score. 
     Law enforcement may use the adherence data and location data to determine if there has been a misuse of a controlled substance, such as opioids. A healthcare provider  310  may use the patient accountability score to determine the efficacy of the treatments to the patient and to modify a treatment program for the patient. Pharmacies and automated dispensers may use the adherence score for automated restocking of inventory using an automated inventory program. Insurance companies  314  may set the price of health insurance based upon the patient accountability score. Insurance companies and healthcare providers may use the patient accountability score to encourage the patient to more carefully adhere to the schedule for taking medicines. 
       FIG. 4  is an embodiment of a distribution and data collection process  400  using the various embodiments of the smart pack system illustrated in  FIGS. 1 through 10 . As illustrated in  FIG. 4 , the drug maker originally manufactures the drug at step  402 . Currently, drugs are being manufactured around the world. Some drug manufacturers produce better drugs than others. In addition, there are a number of instances of counterfeit drugs being manufactured and sold on the open market. Under U.S. law, drug manufacturers must provide data for each lot of drugs it has manufactured, in an effort to prevent the sale of counterfeit drugs or low quality drugs. However, sometimes this data is falsified, resulting in patients receiving low quality or counterfeit medications. If this is discovered, recalls usually occur by manufacturing lot. When filling prescriptions, pharmacies may fill the prescription by drawing from two or more lots to completely fill the prescription. As such, filled prescriptions may include pills that are mixed from different lots. If a recall is issued for a particular lot, the entire filled prescription will have to be recalled, resulting in a waste of medications that may be perfectly fine, assuming that the pharmacy has even kept records of which lots were used to fill the prescription. This can be an expensive process, since some medications can be quite costly. Further, the expiration of the medications from different lots may be different. The expiration date must be set for the expiration date of the lot which has the earliest expiration data, which can also result in a waste of medication. Further, U.S. law requires that a chain of custody be established from the drug manufacturer all the way to the end user. As indicated above, pharmacies may, or may not, actually record which lots of a medication were used to fill a prescription. As a result, the chain of custody of each lot of medication is not established, which is a violation of U.S. drug regulations. 
     At step  404 , of  FIG. 4 , the drug maker performs a spectral analysis of each of the lots of medications and provides the drugs and data to a drug wholesaler. If each of the pills in the blister pockets has undergone spectral analysis, and that data is saved, a detailed record of the strength or efficacy of the medications taken by a patient can be determined by a healthcare provider or other authorized individual. The drug wholesaler then sells the drugs by lot and the lots can be delivered to a smart pack packager, at step  406 . In order to overcome the problems of mixing lots and detecting poor quality drugs, the smart pack packager performs its own spectral analysis of each lot and generates certification data. In this manner, the smart pack packager can certify the efficacy and strength of the drugs and, from that data, can calculate expiration dates and medication strength. In this manner, falsified, or otherwise incorrect, data from a drug manufacturer is detected and a certification is then made by the smart pack packager regarding the efficacy of the drugs. At step  410 , the blister pack smart dispensing packages are filled with pills by lot, with the certification provided by the smart pack packager. 
     Since the smart packs illustrated in  FIGS. 1 and 2  can be manufactured to hold a different number of pills, there is little waste in ensuring that each smart pack only includes a single lot of medication. For example, some smart packs may only have eight or ten blister pockets, while others may have up to 50 blister pockets. Mixing and matching the blister packs for a particular medication allows the blister pack packager to effectively use medications from a single lot in each blister pack with little or no waste. 
     At step  412  of  FIG. 4 , the smart pack packager certification data and lot number data are entered into the electronics and communication package  122  together with the identifying information of the drug, and the smart packs are then delivered to a pharmacy  312 , or automated dispenser  600  ( FIG. 6 ), at step  412 . In some cases, the smart pack packager may be a pharmacy. At step  414 , the pharmacy  312 , or automated dispenser  600 , receives the prescription from the healthcare provider for a particular individual. A secure communication link between the healthcare provider  310  and the automated dispenser  600  is established. In addition, secure authorization codes are also established to prevent any fraud in loading a prescription into an automated dispenser. 
     At step  416  of  FIG. 4 , the pharmacy  312 , or the automated dispenser  600 , loads the patient information into the smart pack  100  and stores this information as to the prescription, the serial number of the smart pack  100 , and other information, on a server/storage on the cloud. The pharmacy  312 , or automated dispenser  600 , then generates a patient label  506 , which is placed on the box  502  ( FIG. 5 ) containing the smart pack  100 . 
     At step  418  of  FIG. 4 , the pharmacy  312 , or automated dispenser  600 , dispenses the smart pack package  500  ( FIG. 5 ) to the user in person, by mail, or in the case of an automated dispenser  600 , at the location of the automated dispenser  600 . At step  420 , the smart pack  100  has been distributed to the user and the electronics and communications package  122  on the smart pack  100  records the time and day; and possibly the location, of opening of the smart pack  100  for each pill in the smart pack  100 . At step  422 , a handheld electronic device, such as a mobile phone, pad computer, or other communication device, that includes a communications package, such as near field, communications, Bluetooth, or other communication protocol, as described in more detail above, communicates with the electronics and communication circuitry  122  on the smart pack  100  and transfers data stored in the electronics and communication package  122  to designated servers and storage on the cloud. The handheld electronic device, or other device, transfers the information to the cloud when it is connected by Wifi, or other connection, to the cloud. At step  424 , a data structure is established, which indicates adherence of the patient to a medication schedule. At step  426 , the adherence data is used by insurance companies to set rates and for other uses. At step  428 , the data structure is analyzed and alarm messages can be sent to third parties, including healthcare professionals, if a patient has not taken needed medication within a certain period. 
       FIG. 5  is a schematic illustration of the smart pack package  500  for the smart pack system. As illustrated in  FIG. 5 , smart pack package  500  includes a box  502  having a prelabel  504 . The prelabel has all of the identifying information for the medication included in the blister pack smart dispensing package  100 . In the example shown in  FIG. 5 , the medication is  20  mg tablets of Lisinopril, a blood pressure medicine, which is shown at the top of the prelabel  504 . The prelabel also includes a bar code, which identifies the medication and a serial number that is associated with the blister pack smart dispensing package  100 . The box  502  also includes a patient label  506 . Prior to dispensing the package illustrated in  FIG. 5 , the pharmacy, or automated dispensing device, prints a patient label  506  that identifies the patient and provides instructions on how to take the medication. The automated smart pack dispenser  600 , illustrated in  FIG. 6 , is capable of printing a patient label  506  from the information provided to the automated dispenser  600  by the healthcare provider  310 . In addition, the pharmacy  312 , or automated smart pack dispenser  600  ( FIG. 6 ) loads the patient data into the blister pack smart dispensing package  100  using the electronics and communication package  122  disposed on the blister pack smart dispensing package  100 . Again, the electronics and communications package  122  may use near field communication techniques or other communication protocols to transmit and receive patient information. A wireless communication system can be used by the pharmacy  312 , or an automated smart pack dispenser  600 , to load the patient data into the blister pack smart dispensing package  100 . 
       FIG. 6  is a schematic illustration of an embodiment of an automated smart pack dispenser  600 . The automated smart pack dispenser  600  has a secure communications link to either a pharmacy  312  or healthcare provider  310 , so that either a pharmacy  312  or healthcare provider  310  can provide patient prescription information to the automated smart pack dispenser  600 . For example, the automated smart pack dispenser  600  may be connected via a secure T1 line to a central office and may send and receive secure communications that are encrypted. In another embodiment, the automated smart pack dispenser  600  may have a Wifi or wired Internet connection, such as Wifi unit  610 , or wired Internet connection  608  and encrypted data can be communicated over the Internet. The automated smart pack dispenser  600  can therefore receive prescription data and dispense prescriptions automatically to authorized individuals. Highly controlled prescriptions, such as opioids, can also be dispensed through the automated smart pack dispenser  600 , through the use of a biometric detector  612 . The biometric detector  612  includes a sensor for sensing biometric information regarding the patient, such as fingerprints, iris detection, retinal detection, or other biometric information. For example, facial recognition may be used and compared to a stored picture of a patient. Typical iris or retinal detectors require the user to stare into the detector to identify the patient as a result of the unique character of the iris or retina. Of course, the biometric data must be transmitted to the automated smart pack dispenser  600  from a healthcare provider, or other source, so that the automated smart pack dispenser  600  can compare the detected biometric data with the stored biometric data. Government IDs can also be used to identify a patient. 
     The automated smart pack dispenser  600  of  FIG. 6  contains the packages of medications such as box  502 , as illustrated in  FIG. 5 , which contains the blister pack smart dispensing package  100  that includes the electronics and communications package  122 , the prelabel  504  and the patient label  506 . When a prescription is received by the automated smart pack dispenser  600 , the patient is prompted to insert a credit or debit card in the card reader  606 , to authorize the transaction. Communication electronics  706  ( FIG. 7 ) disposed within the automated smart pack dispenser  600 , of  FIG. 6 , then generates an encrypted wireless signal that is directed to a specific blister pack smart dispensing package  100 , located in the automated dispenser  600 . In other words, the signal generated by the communication electronics  706  is encoded for a specific box of medication contained in the automated dispenser  600  so that the electronics and communication package  122  ( FIG. 5 ) for that specific box of medication can be programmed with the prescription information for the patient purchasing the medication. The smart pack  100  is then programmed with the prescription information for that patient. Simultaneously, a labeler  716  ( FIG. 7 ) generates a patient label  506  ( FIG. 5 ), which is placed on the box  502  ( FIG. 5 ) for the designated blister pack smart dispensing package  100  that has been designated for that patient in the automated smart pack dispenser  600 . That package is then dispensed through dispenser  602  to the patient. If the prescription is a controlled medicine, such as an opioid, the patient must identify themselves by using the biometric detector  612  prior to dispensing the package to the patient. 
       FIG. 7  is a schematic block diagram of various electronic components of the automated smart pack dispenser  700 . As illustrated in  FIG. 7 , a processor  702  is programmed to control the various components illustrated in  FIG. 7 . Communications electronics  706  receives secure transmissions from a pharmacy or healthcare provider relating to prescriptions to be dispensed by the automated smart pack dispenser  700 . The prescription data is then forwarded to the processor  702 , which stores the prescription data and generates information regarding the patient and the prescription to be dispensed, which is displayed on display screen  604 . The processor then displays a message on the display screen  604  to have the user of the automated smart pack dispenser  700  insert a debit or credit card into the card reader  606 . A government ID can also be read by card reader  606  to identify the user of the automated dispenser  600 . The processor transmits the card information via the communication electronics  706  via the Internet, or a secured T1 line, to a bank or card company for authorization. Authorization data is then received from the bank or card company via the communication electronics  706 . The processor  702  then generates information for the patient label  506  ( FIG. 5 ) from the patient data in the storage  704 . If the prescription calls for a controlled medication, such as an opioid, the processor  702  generates a signal for the display screen  604  that instructs the user to use the biometric reader  612 . For example, a patient may be directed to look into the biometric reader  612  to obtain an iris or retinal scan. In another embodiment, a patient may be asked to place a finger, or a hand, on a fingerprint or hand reader for verification. Of course, if the prescription is not a controlled medication, such as an opioid, a biometric reader is not required, since any authorized adult can sign for the medication. Once the payment has been authorized and the patient label  506  has been applied to box  502  ( FIG. 5 ), the dispenser  714  dispenses the box  502 . 
       FIG. 8  is a schematic illustration of the blister overlay  102 . The blister overlay  102 , as illustrated in  FIG. 8 , contains compounds that age over time. These compounds are plant based material that change color or shading over time. The color and shading is based upon oxidation of these plant based materials that change color and shade as a result of oxidation. The blister overlay  102  is manufactured to change color or shading over a specific time period. The blister overlay  102 , illustrated in  FIG. 8 , is a newly manufactured overlay that is clear. The time period over which the color change occurs in the blister overlay  102 , corresponds to the expiration date of the medication enclosed in the smart pack  100  which can include drugs, supplements, pharmaceuticals, nutraceuticals, orals, solids, liquids, powders and gels, as set forth above. Orders are dispensed by pharmacies and automated dispensers based upon color change tables which have a corresponding expiration date for the contained contents. This information is also loaded into the electronics and communication package  122  and stored in the storage  120 , as illustrated in  FIG. 1 . As such, the color or shade change that occurs in the blister overlay  102  is time based and duration specific. The color or shade change is tied to the drug expiration date so that blister overlays  102  are matched with specific lots of drugs that have a corresponding expiration date. In this manner, the potency and strength and the corresponding expiration date can be matched with the proper blister overlay  102  so that the color change or shading is a visual indication of the potency or viability of the drug. Of course, inhibitors can be used which inhibit the process of color and shade change to slow the process of color and shade change. Further, accelerators can be added to the process to speed up the color and shade changing process. Some of these inhibitors and accelerants use processes for changing the oxidation rate of the materials that cause the color and shade change. In some cases, the price of the contents of the smart pack  100  can be adjusted and the price can be based upon the potency of the contents of the smart pack  100 . In that regard, the price may be reduced for a drug that is less potent. For example, it is known that antibiotics lose potency over time. After several years, the potency may be reduced by a percentage of the original potency. Although the drug is still effective at a reduced potency, the entity selling the drug may wish to reduce the price. The color change and shading can be automatically detected using photoelectric devices, optical sensors, CCD arrays, photographic techniques, and other light sensing techniques. These detected values of color and shade changes can then be stored in the electronics and communication package  122  in storage  120 . In this manner, the smart pack  100  can communicate information relating to potency of the contents of the smart pack  100  and the status of the color/shade change without physically inspecting the package. The stored data can provide information as to whether or not the contents of the smart pack  100  can be used. For certain products, not only does the efficacy of the product change, but some products should not be used after an expiration date. If a product is determined to be in an unsafe range, notifications and certain protocols can be used to contact the user and the proper authorities to confiscate and destroy the product. These communication protocols can be either automatic or manually performed by proper authorities. 
     As also illustrated in  FIG. 8 , in the process of manufacturing the blister overlay  102 , the electronics package  122  is deposited, or placed by various methods, on the blister overlay  102 . In one embodiment, a silicone substrate can be bonded directly onto the blister overlay  102 . Conductive ink can be used to connect the various components and create the conductors  106  ( FIG. 1 ), as illustrated in  FIG. 2 . 
       FIG. 9  is a schematic illustration of the blister overlay  102  that has become shaded or has changed colors as a result of the expiration of a certain time period. In other words, the blister overlay  102  begins to change colors, as illustrated in  FIG. 9 , after a period of time, indicating that the expiration period for the medications in the smart pack is approaching. When the blister overlay  102  is manufactured, the combination of compounds used in the blister overlay determines the time when the blister overlay  102  starts to change colors, or becomes shaded. The blister overlay is matched with the expiration date of a particular lot of medications that has an expiration date corresponding to when the blister overlay  102  changes colors. The blister overlay  102  is then used with a blister pack  104  ( FIG. 1 ) containing pills that have a matching expiration date. 
       FIG. 10  is an illustration of a blister overlay  102  that has changed to be heavily shaded, opaque, or heavily colored, indicating that the medication contained within the blister pack  104  has expired. In this manner, there is a clear indication to the user that the medication contained within the smart pack having the blister overlay  102  has either a diminished efficacy or may be dangerous to take. 
     The foregoing description of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and other modifications and variations may be possible in light of the above teachings. The embodiment was chosen and described in order to best explain the principles of the invention and its practical application to thereby enable others skilled in the art to best utilize the invention in various embodiments and various modifications as are suited to the particular use contemplated. It is intended that the appended claims be construed to include other alternative embodiments of the invention except insofar as limited by the prior art.