METHOD AND APPARATUS FOR COMMUNICATING DRUG LABEL AND SAFETY INFORMATION
FIELD OF THE INVENTION
[0001] The present invention relates generally to methods and apparatus for communicating information currently dispensed by pharmaceutical companies on their drug labels, as well as the ability to communicate information that is not currently available on a drug label due to the size of the label and the lack of technology currently associated with the nature of a drug label. Moreover, the present invention applies more particularly to a method and apparatus for communicating drug label and safety information over a communication network.
BACKGROUND
[0002] Over the life of a pharmaceutical product new data about the product is developed and learned. Currently, there is no means by which to advise a patient in real-time about updated safety information other than via direct communication with their physician or pharmacist. Additionally, this direct communication with these healthcare professionals lacks standardization because it introduces the aspect of human interpretation to the communication channel. Therefore, the present invention is directed towards enhancing the availability of information regarding pharmaceutical products to patients. Finally, in extreme situations where vital safety information is learned about a pharmaceutical product, which information causes a clinical trial to be stopped or a product to be withdrawn, there is currently no means by which to immediately communicate to patients
that they should immediately stop taking the medication and/or contact their healthcare professional. Under the present scenario, each healthcare professional must contact each patient to advise them of this new information which could incur a substantial delay and result in jeopardized patient safety.
[0003] In addition, in order to submit a clinical study application regarding a new drug application to a federal agency, a pharmaceutical sponsor must conduct clinical trials. Each country in which a clinical trial is conducted has specific labeling requirements for their products, which requirements often require a translation of drug label text into a native language. Currently specific drug packages must be labeled for use in a particular country or countries (by use of a multi-lingual label). In order for particular drug supplies to be utilized in a country that is not anticipated, manual re-labeling must occur. This decreases the flexibility of use of drugs in clinical trials.
[0004] Furthermore, all investigational products being studied through a clinical trial must be labeled with expiration dates. Over the course of a clinical trial, the investigational products may be re-certified to confirm the continued validity of the investigational products. In a particular clinical trial there may be several different investigational products being dispensed, each of which have their own expiration dates. Currently, re-evaluation dates for these products cause pharmaceutical trial sponsors to engage in manual re-labeling of all drug supplies, including those that have been dispensed to investigational sites around the globe. This may occur several times over the life of a study, incurring considerable cost in terms of man-hours, travel costs and administrative burdens.
[0005] Currently patients are informed of safety information relating to medicinal
products that they may be exposed to over the life of a clinical trial during an Informed Consent process. The Informed Consent document is a legal document that is often written at a fairly high educational level, i.e., 12th grade reading level. It is hoped that the investigator or study coordinator that conducts the Informed Consent process with the patient explains anything that the patient does not understand. When new safety information becomes available through the pharmaceutical company a new Informed Consent is drafted. The investigational site must then re-consent the patient. Whether the patient realizes the edits to the safety profile is somewhat unknown as the investigator might "glaze over" over the updates or simply ask the patient if they consent to continue in the trial. Of course, that is not the intention, but there is nothing in place to prevent it from happening. It is important to note that the patient does receive a copy of their signed Informed Consent to bring home with them.
[0006] In some cases visits are spaces rather far apart - this is particularly the case in late phase (stage III - V) studies. In situations such as this, there may be a long time lapse between when updated safety information becomes available in the Informed Consent and when the patient is informed of the updated safety information (i.e., the new Informed Consent document is issued on May 1, the patient's next visit is on September 1). The patient may not wish to continue in the trial if the new safety information includes risk of developing liver abnormalities and the patient has a family history of liver problems. [0007] The present invention is therefore directed to the problem of developing a method and apparatus for providing real-time re-labeling of drug supplies to meet the regulatory requirements of any given country without the necessity of manual re-labeling while enabling and enhancing efficient and simple updating of drug labels even after drug
supplies have been distributed throughout the world, as well as providing updated related safety information as rapidly as possible once available.
SUMMARY OF THE INVENTION
[0008] The present invention solves these and other problems by providing an electronic drug label and at least a one-way communication channel between a pharmaceutical sponsor and the patient/subject through an electronic drug label display. This display can show updated drug labels as well as related safety information as soon as it becomes available.
[0009] According to one aspect of the invention, a communications terminal for transmission of drug label and related safety information includes a memory and an interface via which the pharmaceutical manufacturer may update the drug label and related safety information. Moreover, the manufacturer interface may comprise a patient/subject interface via which drug labels may be updated. Furthermore, the communications terminal may include a process to verify information regarding the applicable drug supplies and regulatory/language requirements necessary for a particular patient/subject in a particular country. Still, the communications terminal may include a transmitter to send updated drug label and related safety information to the electronic drug labels attached to drug packages, each of which is uniquely addressable. [0010] According to another aspect of the present invention, an apparatus for enabling remote updating of drug labels and related safety information includes a database, a server and a communications interface. The database stores drug labels and related safety information and permits updating of the drug labels and related safety information stored
therein. The server enables healthcare professionals to access the database to update and store revised drug label and related safety information associated with uniquely addressable drug packages. The server authenticates the user updating the label and related safety information prior to accessing the database and performs encryption and decryption of communications between the users and uniquely addressable drug packages. The communications interface provides a link to the communications system and transmits new information directed to a particular drug package in accordance with the regulatory/language requirements upon initiation of authentication of the authorized user and the investigational supplies. Each patient receives a baseline number/allocation number that is unique to the individual. Each kit of investigational product has unique numbers assigned.
[0011] According to one aspect of the present invention, a communications terminal for communicating drug label and related safety information includes a memory and a user interface. The memory stores drug labels and related safety information to be applied to drug packages. The user interface enables a user to update the drug labels and related safety information. Moreover, the user interface may comprise a remote user interface via which a user can access the memory and update the drug labels and related safety information remotely. Furthermore, the communications terminal may include a process to verify security information from the user prior to enabling the user to update the drug labels and related safety information. Still, the communications terminal may include a transmitter to send updated drug label and related safety information to electronic drug labels attached to drug packages, each of which are uniquely addressable. [0012] According to another aspect of the present invention, an apparatus for enabling
remote updating of a drug label and related safety information includes a database, a server and a communications interface. The database stores drug labels and related safety information and permits updating of the drug labels and related safety information stored therein. The server enables users to access the database and store and update a drug label and related safety information associated with uniquely addressable drug packages. The server authenticates the users prior to accessing the database and performs decryption and encryption of communications between the users and uniquely addressable drug packages. The communications interface provides an interface to a communications system and transmits a new drug label or updated drug label information and related safety information directed to a particular drug package to which an addressed electronic drug label is attached upon initiation of an authenticated user.
[0013] According to still another aspect of the present invention, a method for updating a drug label and related safety information remotely includes disposing an electronic drug label on a packaging of the drug and transmitting an updated drug label and related safety information to the electronic drug label. Furthermore, the method includes receiving the updated drug label and related safety information by the electronic drug label and updating a display of the electronic drug label with the updated drug label and related safety information.
[0014] According to yet another aspect of the present invention, an apparatus for enabling a drug manufacturer to remotely update a drug label and related safety information on a drug package includes an electronic drug label, a communications channel and a terminal. The electronic drug label includes a receiver and a display. The communications channel provides communications between the drug manufacturer and the electronic drug label.
The terminal is coupled to the communications channel, accepts a revised drug label and related safety information_and transmits the revised drug label and related safety information to the electronic drug label. Upon receipt, the electronic drug label updates the display with the revised drug label and related safety information. [0015] According to yet another aspect of the present invention, an electronic drug label includes a display for displaying drug-labeling and related safety information, a receiver to receive updated drug labeling and related safetyjnformation and a processor to update the display with the received updated drug labeling and related safetyjnformation. Moreover, the electronic drug label may include an attachment to couple drug packaging that includes drugs to the electronic label.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG 1 depicts an exemplary embodiment of an apparatus for enabling a drug manufacturer to store and update drug label and safety information on a drug packaging remotely according to one aspect of the present invention.
[0017] FIG 2 depicts a block diagram of an exemplary embodiment of an electronic drug label according to another aspect of the present invention.
[0018] FIG 3 depicts a flow chart of an exemplary embodiment of a method for enabling a drug manufacturer to store, display and update drug label and safety information about a drug on packaging of the drug according to yet another aspect of the present invention. [0019] FIG 4 depicts an exemplary embodiment of an electronic drug label and packaging according to still another aspect of the present invention. [0020] FIG 5 depicts another exemplary embodiment of an electronic drug label and
packaging according to yet another aspect of the present invention.
[0021] FIG 6A depicts another exemplary embodiment of an electronic drug label and packaging according to still another aspect of the present invention.
[0022] FIG 6B depicts another exemplary embodiment of a drug packaging according to yet another aspect of the present invention.
[0023] FIG 6C depicts another exemplary embodiment of an electronic drug label and packaging according to still another aspect of the present invention.
[0024] FIGs 7A-C depict another exemplary embodiment of an electronic drug label and packaging according to yet another aspect of the present invention.
[0025] FIG 8 depicts another exemplary embodiment of an electronic drug label and packaging according to still another aspect of the present invention.
DETAILED DESCRIPTION
[0026] It is worthy to note that any reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention.
The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.
[0027] Turning to FIG 1, shown therein is an exemplary embodiment of a system 10 for enabling a drug manufacturer to update the labels on drug packages, such as those used in clinical studies or research. At the heart of the system exists an electronic drug label 16, with the capability to be updated, as well as a communication channel between the electronic drug label 16 and a drug manufacturer (or its agent or representative). Multiple
elements of the system 10 shown in FIG 1 create this communication channel as will be discussed below, however, any communication channel may suffice. [0028] The embodiment 10 includes a server 11a, which is accessible by one or more employees of the drug manufacturer working at one or more computers 14a-c via a network 15, such as an intranet or local area network. Employees are authenticated when accessing the network 15 and all communications within the network are secure. Server 1 Ia comprises a standard server capable of performing traditional networking authentication and encryption functions, as well as data forwarding functions. [0029] Other servers l ib similar to server 1 Ia at potentially other drug manufacturers (or other offices of the same manufacturer) may exist. In FIG 1, the other computers that access server 1 Ib are not shown for simplicity purposes.
[0030] A central database 17 for all manufacturers may be provided (under control, for example, of the regulatory agency, e.g, the Food and Drug Administration), or each manufacturer may control its database 17.
[0031] Server 11a communicates with server 13 via the Internet or other network 12 and these communications are conducted securely, such as via encryption. Server 13 is also a standard server performing traditional networking functions.
[0032] Server 13 stores all drug labeling information in database 17, which is secured as well. For example, the data stored in the database 17 may be stored in encrypted form, and therefore not accessible to even the database operators without the encryption key that is managed by the drug manufacturer. Server 13 may store drug labeling information from multiple drug manufacturers, such as those represented by server l la and server 1 Ib. Each record in the database is associated with a unique address that
uniquely identifies the drug manufacturer, and the drug package of that drug manufacturer to which the associated drug label belongs. This unique address is used in the communication process to uniquely address a receiver located in the electronic drug label 16. As the drug label information may include proprietary information or highly valuable trade secret information, these records are protected from external sources and unauthorized parties via encryption, for example.
[0033] Server 13 also has a communications path via network 18 to each of the one or more electronic drug labels 16a-c in use. This communication is also performed securely, such as via encryption. The drug label information may be encrypted from the server 11a to the electronic label 16a-c, at which point the information is decrypted for the first time so that the information is stored and communicated from server 1 Ia to the electronic drug label 16a-c in encrypted form, thereby rendering this information useless to anyone without the proper decryption key.
[0034] Communication network 18 may be the same as communications network 12 or different. One example of communications network 18 is a satellite communications network. This network may communicate via geosynchronous orbiting satellite or multiple low earth orbiting satellites, or any combination of the two. In this embodiment, the satellite communications network broadcasts the encrypted drug label to the various electronic labels. Only those with the proper address will decrypt the transmission, and only those with the proper decryption key will successfully decrypt the transmission. As the electronic drug label need only receive the data, the communication will only require a small antenna, such as used on a cellular phone.
[0035] According to one aspect of the present invention, an electronic label is attached to
the packaging of a drug. For example, the drug may be packaged in a blister pack that contains pharmaceutical product. Alternatively, the drug may be packaged in a vial. In either case, the electronic drug label includes an attachment that couples the electronic drug label to the drug packaging. For example, the electronic label may be designed to slide around the outside of a pill bottle for containment of pharmaceutical product, or slide around the outside of liquid containing bottle for containment of pharmaceutical product. Alternatively, the electronic label can be built into the front of a "clip" that is fastened to the end of a tube for topically applied pharmaceuticals.
[0036] According to another aspect of the present invention an exemplary embodiment of the attachment includes a screw-in receptacle that accepts a top or bottom of the vial so that the vial screws into the electronic drug label.
[0037] According to still another aspect of the present invention, an exemplary embodiment of the attachment includes a circular space disposed in the electronic label into which the vial can be placed and held. For example, a hole having several plastic extensions that bend away from the hole in the direction of insertion when the vial is inserted into the hole thereby placing a spring-like grip on the vial and making removal of the vial difficult.
[0038] Turning to FIG 2, the electronic drug label 20 includes a display 23, such as an
LCD display, capable of displaying up to one or two pages of text. A scroll button (not shown) on the display can be used to enable the viewer to move up and down the pages of text.
[0039] The electronic drug label 20 also includes a processor 22 capable of decrypting a
received transmission that includes updated drug label information. The processor 22 then updates the display 23 with the received updated drug label information, either by appending or replacing the information received with the existing information, depending upon the change indicated.
[0040] The electronic drug label 20 also includes a power source 24, such as a small lithium battery used in calculators or other small electronic devices. The electronic drug label also includes an antenna (not shown) designed for the proper communications system.
[0041] The electronic drug label 20 also includes a communications interface 21, such as a receiver that can receive a communication from a satellite, RF signal, cell tower, or the like. This communications interface need only be a one-way receiver as there is no requirement for a return channel to the drug label terminal from the electronic label. The receiver is individually addressable by the transmitter. Upon receipt of a transmission, the receiver verifies the address, and upon a match forwards the decoded data to the processor 22 for subsequent processing, including for example, decryption. [0042] The system also includes a docking station or terminal to communicate agency required drug label and safety information with multiple electronic drug labels for downloading of vile content information. This docking station can be a server coupled to a database that stores all of the required drug label information and is accessible via the server only to authenticated users. Moreover, the database contents are stored and transmissions are performed in a secure manner, such as with encryption. Security safeguards are employed by the server and database to prevent hacking or other
unauthorized access to the stored information and to prevent uploading of new labeling information by unauthorized parties.
[0043] Turning to FIG 3, shown therein is a flow chart of an exemplary embodiment of a method for enabling a drug manufacturer to store, display and update drug label and safety information about a drug on packaging of the drug.
[0044] In element 31, the exemplary embodiment 30 disposes an electronic drug label on a packaging of the drug and displays drug label and safety information on a display of the electronic drug label that is attached to the packaging of the drug.
[0045] In element 32, the exemplary embodiment 30 enables storing of drug label and safety information about a drug and/or editing of a stored version of the drug label and safety information by an authenticated user.
[0046] In element 33, the exemplary embodiment 30 transmits an updated drug label and safety information to the electronic drug label. The exemplary embodiment 30 could also transmit new drug label and safety information for the first time to a drug package, if no drug label and safety information had been previously included in the electronic drug label.
[0047] In element 34, the exemplary embodiment 30 receives the updated drug label and safety information by the electronic drug label (also possibly for the first time).
[0048] In element 35, the exemplary embodiment 30 updates a display of the electronic drug label with the updated drug label and safety information (or displays this information for the first time).
[0049] In another exemplary embodiment, a docking station can be provided into which a
holder of the drug package can place the electronic drug label so that the label can be updated. This embodiment provides a simple communication channel to the electronic label, thereby avoiding a satellite or cellular transmission to forward the drug label and safety information. In this embodiment, the docking station is in communication with the drug label database via the Internet, for example. So that when the electronic drug label is coupled to the docking station the docking station reads the unique identification number associated with the electronic drug label, accesses the drug label database and obtains the latest drug label and safety information. This information is then downloaded into the electronic drug label via an interface (such as a USB port) between the docking station and the electronic drug label. In one embodiment, the docking station can comprise a personal computer dedicated (or at least have stored thereon a program that can be selected) to executing a program to perform the drug label and safety information updating function. The docking station can be located in a pharmacy or doctor's office so that when a patient returns for a prescription refill, part of the refill process includes coupling the electronic drug label with the docking station. [0050] Alternatively, the docking station could be any personal computer having an interface that mates with a like interface on the electronic label, such as a USB port. In this embodiment, a patient, subject, pharmacist, healthcare professional or doctor might access a website that would then lead the user through a series of steps to couple the electronic drug label to the interface and then access the database and download the latest (or updated) drug label and safety information. [0051] According to another aspect of the present invention, the user could be required to
scroll through the display screen on the electronic drug label to indicate that the user read the updated drug label and safety information before turning off an alarm so that a patient would be sufficiently informed upon each update. In addition, the electronic drug label might send a message back to the manufacturer (or the doctor) that the updated label and safety information has not been read by the patient/subject, thereby prompting a call or a visit from a healthcare professional to the patient/subject, as necessary. For example, the electronic drug label might flash an update on the screen indicating that new safety data is available. By pressing a control button the user could see the new drug label and safety information, which might include language to the effect of:
"If the safety data that you have just read influences your decision to continue in this clinical trial, please contact your Investigator site to discuss your concerns. " [0052] Additionally, the safety information would be available on the container of the medicinal product in a scroll-through list. Therefore, if a patient experienced a headache while they were golfing, if they had their pill bottle with them, they could look to see whether headaches are a potential side effect of the drug.
[0053] Turning to FIG 4, shown therein is an exemplary embodiment 40 of an electronic drug label and packaging according to another aspect of the present invention. In this embodiment 40, a pill container (this container may hold liquids as well) screws into the electronic drug label 42, which includes a display screen 44, control buttons 43 and an electronic receiver and digital chip 45. The control buttons 43 enable a user to scroll through and adjust the display to read the contents of the drug label and related safety information. The electronic receiver and digital chip 45 provide communications between the manufacturer and the electronic drug label 42. The digital chip provides the
necessary control functions and memory needed to operate the display, perform decryption and other ancillary functions.
[0054] Display screen 44 can be of the type used in calculators or handheld devices, such as palm pads. The electronic receiver 45 can be that used in a cell phone or a GPS receiver, but need only include receive functions.
[0055] Turning to FIG 5, shown therein is a mated version of the embodiment shown in FIG 4.
[0056] Turning to FIG 6A, shown therein is a front view of another exemplary embodiment 60 of an electronic drug label and packaging according to yet another aspect of the present invention. This embodiment 60 includes a container 61, a display screen 62, control buttons 63. The top portion 64 attaches to the drug (e.g., pill, gel, liquid, etc.) container 61. FIG 6B shows the embodiment 60 in a side view. FIG 6C shows a back view of embodiment 60.
[0057] Turning to FIG 7 A, shown therein is a front view of another exemplary embodiment 70 of an electronic drug label and packaging according to yet another aspect of the present invention. FIG 7B shows a side view of embodiment 70. The electronic drug label portion 73 of embodiment 70 includes a display screen 71, control buttons 72 and electronic circuitry (not shown) as discussed above to provide communications, control and functionality. FIG 7C shows a back view of the embodiment 70. This embodiment 70 includes a container 76, such as a blister pack with containment cells 75. [0058] Turning to FIG 8, shown therein is a front view of another exemplary embodiment 80 of an electronic drug label and packaging according to yet another aspect of the present invention. The electronic drug label portion (top half) of embodiment 80 includes
a display screen 81, control buttons 82 and electronic circuitry (not shown) as discussed above to provide communications, control and functionality. Embodiment 80 includes a container 83, such as a blister pack with containment cells 84.
[0059] Although various embodiments are specifically illustrated and described herein, it will be appreciated that modifications and variations of the invention are covered by the above teachings and are within the purview of the appended claims without departing from the spirit and intended scope of the invention. For example, certain communications methods are disclosed herein, but many other are possible without departing from the scope of the present invention. Moreover, certain drug forms are used in the exemplary embodiments, however, the drug forms may include any form of a drug, such as solid, liquid, gel or gas. Furthermore, these examples should not be interpreted to limit the modifications and variations of the invention covered by the claims but are merely illustrative of some possible variations.