Source: https://patents.google.com/patent/US8930207B2/en
Timestamp: 2019-05-22 09:56:56
Document Index: 581676170

Matched Legal Cases: ['application No. 2008323993', 'application No. 2008', 'application No. 200880124312', 'application No. 200880124312', 'application No. 2010123012', 'application No. 2010']

US8930207B2 - Medical product dispensing systems and methods - Google Patents
US8930207B2
US8930207B2 US12/265,888 US26588808A US8930207B2 US 8930207 B2 US8930207 B2 US 8930207B2 US 26588808 A US26588808 A US 26588808A US 8930207 B2 US8930207 B2 US 8930207B2
US20090125324A1 (en
2008-11-06 Application filed by GlaxoSmithKline LLC filed Critical GlaxoSmithKline LLC
Based on the particular medical product 20 being requested and, when required, the general personal information, controller 16 determines whether the purchase request is a first or initial request for the particular medical product 20 by the purchaser. In other embodiments where no personal information is available, controller 16 can ask the purchaser whether the purchase request is a first or initial request or a second or subsequent request for the particular medical product 20 by the purchaser. If the request is an initial request, controller 16 executes self-selection algorithm 24. However, if the request is not an initial request, but rather is a second or subsequent request, the controller 16 executes de-selection algorithm 26.
System 10 provides a patient driven system, located at the point-of-sale, that establishes the patient identification, accepts first and subsequent purchase requests for a particular medical product 20, uses algorithms 24, 26 to determine if that patient is eligible to receive or continue to receive that medical product, provides warning and heeding information to the purchaser about the medication via data entry and communication device 14-1 in verbal, display and/or printed form, reviews and calculates any limitation or compliance requirements as indicated in the approved labeling or set by governmental agencies, and completes the sales transaction via payment device 14-4, if desired, and dispenses the medical product when appropriate.
In another example, system 10 can communicate a follow-up reminder directly to the purchaser. In some embodiments, system 10 can send an e-mail message, an electronic phone message, a text message, a mailed letter directly to the purchaser reminding the purchaser to, for example, verify their blood pressure is below a predetermined limit or to see their physician if the signs and symptoms of the condition being treated become worse.
The systems and methods according to the present disclosure, by eliminating the need to interact with a pharmacist or learned health care intermediate, allow the dispensing of non-prescription, behind-the-counter medical products in locations previously impossible.
Once selected, method 100 includes a first developing step 104, where a set of initial dispensing criteria a developed. The set of initial dispensing criteria for the particular medical product includes criteria sufficient to a responsible regulatory agency, such as the FDA, to authorize changing the status of the medical product to the non-prescription status. Next, method 100 includes a second developing step 106, where a set of selection questions based on the set of initial dispensing criteria are developed.
In the illustrated example where the desired medical product 20 is a cholesterol lowering medicine such as those available in the “statin” class of drugs, which are commercially available from the assignee of the present application, method 150 determines, at step 162, whether the purchase request by the particular purchaser for that particular product 20 is a first purchase request 164 or a second request 166. It should be recognized that in other examples of algorithms 24, 26 for other medical products, method 150 may only need to differentiate first purchases from second purchases, while still other algorithms 24, 26 for other medical products may require method 150 to differentiate each purchase from another
When method 150 determines at step 186 that the male purchaser is within the appropriate age bracket (i.e., 45 or older), the method requires the purchaser to input their cholesterol level at step 188. Again, the cholesterol level can be inputted at step 178 by any method discussed herein above. After receiving the purchaser's cholesterol level, method 150, via self-selection algorithm 24, compares this level to a predetermined therapy level at step 190. For example, if the purchaser's cholesterol level is above the predetermined therapy level shown as above 170 mg/dL, then method 150 continues to utilize the self-selection algorithm 24 as shown in FIG. 8 d.
Returning for a moment to FIG. 8 a, when method 150 determines at step 170 that the purchaser is a second time purchaser of the particular medical product 20 and is female, method 150 continues to utilize the de-selection algorithm 26 as shown in FIG. 8 f. Referring now to FIG. 8 f, method 150, based on information verified during steps 156, determines whether the female purchaser is still below the age of 55 and verifies this age with the purchaser at step 272. If the purchaser is below the age of 55, namely is within the child bearing years, method 150 determines whether the purchaser is pregnant at step 274, and if not, whether the purchaser is incapable of becoming pregnant at step 276.
After receiving the purchaser's cholesterol level, method 150, via de-selection algorithm 26, compares this level to a maximum predetermined therapy level at step 290-1 and a minimum predetermined therapy level at step 290-2. For example, if the purchaser's cholesterol level is within the therapy level of 130 mg/dL to 170 mg/dL, then method 150 continues to utilize the de-selection algorithm 26 as shown in FIG. 8 d.
Matching algorithm 32 is configured to provide exemplary symptoms or disease-states to the purchaser via data entry and communication device 14-1 in a visual or auditory form. As used herein a “visual form” shall mean that the exemplary symptom or disease-state is provided to the purchaser in non-textual form such as, but not limited to, a picture. In this manner, matching algorithm 32 allows the purchaser to match their particular symptom or disease-state to the exemplary symptom or disease-state presented. Once the purchaser identifies their symptom or disease-state via matching algorithm 32, controller 16 provides the purchaser with a list via device 14-1 of one or more medical products 20 within vending machine 12 that are appropriate for that symptom or disease-state.
In some embodiments, it is contemplated by the present disclosure for system 10 to be configured for distribution of one particular medical product. Here, system 10 can have matching algorithm 32 for only that particular medical product. In use, the purchaser would use system 10 for the particular medical product they are interested in purchasing by approaching the system advertised for that particular medical product. Then, controller 16 resident on system 10 can allow the purchaser to access to matching algorithm 32 and provide a plurality of exemplary symptoms or disease-states for the particular medical product to the purchaser via the data entry and communication devices 14. In this manner, the purchaser can select one or more symptoms or disease-states from the plurality of exemplary symptoms or disease-states when the one or more symptoms or disease-states match those currently being experienced by the purchaser. Once a symptom or disease-state that the purchaser is experiencing has been selected from the matching algorithm 32, system 10 can operate in the manner discussed herein above. More particularly, system 10 can initiate the use of the selection and/or de-selection algorithms 24, 26, respectively.
However, instead of dispensing the medical products 20 a, 20 b, 20 c, and 20 d directly from system 310 as with system 10, system 310 is configured to dispense a record 340 for the medical product selected by a purchaser. Here, system 310 dispenses the record 340 only if the purchaser qualifies for the medical products 20 a, 20 b, 20 c, and 20 d as determined by the product specific self-selection algorithm 24, or limited by the label, manufacturer, retailer or other governmental agencies.
System 310 finds use with any of the methods 40, 60, 80, 100, and 150 discussed herein above. However, instead of dispensing the medical product, system 310 generates record 340. Once record 340 has been generated, the purchaser can present the record to a sales associate located at the point-of-sale.
In a further embodiment of the above noted method, the method can further include providing warning and caution data to the purchaser during the self-selection process.
Accordingly, a second embodiment is directed to a method of dispensing a medical product from a vending machine in a general sales location, including: accepting a purchase request at the vending machine from a purchaser for a particular restricted distribution medical product; determining if the purchase request is an initial purchase request or a subsequent purchase request by the purchaser for the particular medical product; accessing a self-selection algorithm for the particular medical product if the purchase request is the initial purchase request; accessing a de-selection algorithm for the particular medical product if the purchase request is the subsequent purchase request; requiring the purchaser to input an answer to each of a plurality of questions generated by the self-selection algorithm or the de-selection algorithm; and controlling the vending machine, via the self-selection algorithm or the de-selection algorithm, to dispense or not dispense the particular medical product based the answers.
1. A method for distributing a restricted distribution medical product, comprising:
storing an electronic self-selection algorithm related to the restricted distribution medical product on a controller connected to an interactive computer controlled device, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the restricted distribution medical product and (2) information provided by a potential purchaser relating to the potential purchaser's medical condition including areas of critical interest related to the potential purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not starting treatment;
completing by the potential purchaser through the device, an electronic self-selection process according to the electronic self-selection algorithm, for a first purchase of the restricted distribution medical product;
generating, by the controller, based on the completed electronic self-selection process, a transaction record for the restricted distribution medical product, without interaction between the potential purchaser and a licensed practitioner, for the first purchase request for the restricted distribution medical product;
storing an electronic de-selection algorithm related to the restricted distribution medical product, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the potential purchaser relating to the potential purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit to continue treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not continuing treatment;
unsuccessfully performing by the potential purchaser through the device, an electronic de-selection process according to the electronic de-selection algorithm, for a second or subsequent purchase request of the restricted distribution medical product; and
denying by the controller based on the unsuccessfully performed electronic de-selection process, the second or subsequent purchase request of the restricted distribution medical product, without interaction between the potential purchaser and a licensed practitioner, when the potential purchaser failed to successfully complete the electronic de-selection process.
2. The method of claim 1, further comprising collecting information from the potential purchaser as part of the electronic self-selection process.
3. The method of claim 2, further comprising customizing the information based on the electronic self-selection process, the electronic de-selection process, and any combinations thereof.
4. The method of claim 2, further comprising customizing the information based on purchaser specific biometric data.
allowing the purchaser to purchase the restricted distribution medical product if the potential purchaser successfully completes the electronic self-selection process or the electronic de-selection process.
6. The method of claim 5, wherein the transaction record includes proof of purchase of the restricted distribution medical product.
8. The method of claim 1, further comprising collecting purchaser specific biometric data from the potential purchaser as part of the electronic self-selection process, wherein the biometric data is representative of one or more physiological conditions of the potential purchaser.
9. The method of claim 8, wherein collecting the biometric data comprises controlling the controller to measure the biometric data of the potential purchaser.
10. The method of claim 8, further comprising analyzing the purchaser specific biometric data as part of the electronic self-selection process.
11. The method of claim 8, wherein collecting the purchaser specific biometric data comprises requesting the potential purchaser to manually enter the biometric data into the controller.
12. The method of claim 8, wherein collecting the purchaser specific biometric data comprises allowing the potential purchaser to scan or read the biometric data into the controller from a user provided medium.
13. The method of claim 8, wherein collecting the purchaser specific biometric data comprises:
controlling the controller to retrieve the purchaser specific biometric data from the potential purchaser supplied biometric measurement device.
14. The method of claim 8, wherein collecting the purchaser specific biometric data comprises:
authorizing, by the electronic self-selection process, the controller to access the purchaser specific biometric data on the database via a network connection.
15. The method of claim 1, wherein the restricted distribution medical product comprises a non-prescription, behind-the-counter medical product.
16. The method of claim 1, further comprising controlling the controller to provide instructions to the potential purchaser in the event that the controller determines that the potential purchaser did not successfully complete the electronic self-selection process, the instructions including steps needed to successfully complete the electronic self-selection process.
17. The method of claim 1, further comprising controlling the controller to provide instructions to the potential purchaser in the event that the controller determines that the potential purchaser did not successfully complete the electronic de-selection process, the instructions including steps needed to successfully complete the electronic de-selection process.
18. The method of claim 1, wherein the electronic de-selection process comprises automatically limiting a length of therapy of the restricted distribution medical product to a predetermined length.
19. The method of claim 1, further comprising providing warning and caution data to the potential purchaser as part of the electronic self-selection process and/or the electronic de-selection process.
20. The method of claim 1, wherein allowing the potential purchaser of the restricted distribution medical product to access the electronic self-selection and electronic de-selection processes comprises:
allowing the potential purchaser of the restricted distribution medical product to access the electronic self-selection and electronic de-selection processes via the Internet.
requiring the potential purchaser to retrieve the restricted distribution medical product from a retail shelf in a retail location; and
requiring the potential purchaser to take the transaction record and the restricted distribution medical product to a sales associate at the retail location.
22. A method for distributing a restricted distribution medical product, comprising:
storing an electronic self-selection algorithm related to the restricted distribution medical product on a controller of an interactive device, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the restricted distribution medical product and (2) information provided by a purchaser relating to the purchaser's medical condition including areas of critical interest related to the purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting, that outweighs the risk of not starting, treatment with the restricted distribution medical product;
completing by a purchaser of the restricted distribution medical product to access and complete, via a telephone operatively connected to the interactive device, the electronic self-selection algorithm for a first purchase request of the restricted distribution medical product;
generating, by the controller, based on the completed electronic self-selection process, a transaction record for the restricted distribution medical product without interaction between the purchaser and a licensed practitioner, for the first purchase request for the restricted distribution medical product;
storing an electronic de-selection algorithm related to the restricted distribution medical product on the controller, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the purchaser relating to the purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit, that outweighs the risk, to continue treatment with the restricted distribution medical product;
unsuccessfully performing by the purchaser through the device, an electronic de-selection process according to the electronic de-selection algorithm, for a second or subsequent purchase request for the restricted distribution medical product; and
denying by the controller based on the unsuccessfully performed electronic de-selection process, the second or subsequent purchase request of the restricted distribution medical product, without intervention between purchaser and a licensed practitioner, when the purchaser fails to successfully complete the electronic de-selection process.
23. The method of claim 22, further comprising collecting purchaser specific biometric data from the potential purchaser as part of completing the electronic self-selection process.
24. The method of claim 23, further comprising analyzing the purchaser specific biometric data as part of the electronic self-selection process.
25. The method of claim 23, wherein collecting the purchaser specific biometric data comprises requesting the purchaser to manually enter the biometric data into the controller.
26. The method of claim 22, wherein the restricted distribution medical product comprises a non-prescription, behind-the-counter medical product.
27. The method of claim 22, further comprising collecting information from the purchaser as part of completing the electronic self-selection process.
28. A method for dispensing a restricted distribution medical product, comprising:
identifying a restricted distribution medical product having a restricted distribution status;
storing a supply of the restricted distribution medical product in the vending machine;
storing an electronic self-selection process related to the restricted distribution medical product on the controller, wherein the electronic self-selection includes an algorithm evaluates (1) information identified by a governmental agency and included on the label of the restricted distribution medical product and (2) information provided by a purchaser relating to the purchaser's medical condition including areas of critical interest related to the purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting, that outweighs the risks associated with not starting, treatment with the restricted distribution medical product;
controlling the vending machine, via the controller, to dispense a first sales unit of the restricted distribution medical product, without interaction between the purchaser and a licensed practitioner when the purchaser successfully completes the electronic self-selection process for an initial purchase request for the restricted distribution medical product;
controlling the vending machine, via the controller, not to dispense the first sales unit of the restricted distribution medical product when the purchaser does not successfully completes the electronic self-selection process;
storing an electronic de-selection process including an algorithm related to the restricted distribution medical product on the controller, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the purchaser relating to the purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit to continue, that outweighs the risks associated with not continuing, treatment with the restricted distribution medical product;
unsuccessfully performing by the purchaser through the vending machine, an electronic de-selection process according to the electronic de-selection algorithm, for a second or subsequent purchase request for the restricted distribution medical product; and
denying by the controller based on the unsuccessfully performed electronic de-selection process, the second or subsequent purchase request of the restricted distribution medical product, without intervention between the purchaser and a licensed practitioner, when the purchaser failed to successfully complete the electronic de-selection process.
29. A method of dispensing a restricted distribution medical product from a vending machine in a general sales location, comprising:
accepting a purchase request at the vending machine from a purchaser for a restricted distribution medical product;
accessing a dispensing process of the vending machine for the restricted distribution medical product, wherein the dispensing process stores an electronic self-selection algorithm related to the restricted distribution medical product, and requires the purchaser to input an answer to each of a plurality of questions, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the restricted distribution medical product and (2) information provided by the purchaser relating to the purchaser's medical condition including areas of critical interest related to the purchaser's medical history and signs and symptoms of the condition to be treated and biometric data being representative of one or more physiological conditions of the purchaser, and, based on the evaluation, determines whether there is a benefit of starting, that outweighs the risks associated with not starting, treatment with the restricted distribution medical product;
dispensing the restricted distribution medical product, without interaction between the purchaser and a licensed practitioner based, at least in part, on the biometric data and answers input by the purchaser;
accessing a second or subsequent dispensing process of the vending machine for the restricted distribution medical product, wherein the dispensing process stores an electronic de-selection algorithm related to the restricted distribution medical product on the controller, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the purchaser relating to the purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit to continue, that outweighs the risks associated with not continuing, treatment with the restricted distribution medical product;
unsuccessfully performing through the vending machine, an electronic de-selection process according to the electronic de-selection algorithm, for a second or subsequent purchase request for the restricted distribution medical product; and
denying by the vending machine based on the unsuccessfully performed electronic de-selection process, the second or subsequent purchase request of the restricted distribution medical product, without intervention between the purchaser and a licensed practitioner, when the purchaser failed to successfully complete the electronic de-selection process.
30. A method of switching a prescription medical product to a non-prescription, restricted distribution medical product and dispensing same, comprising:
selecting a medical product having a prescription status;
developing a set of initial dispensing criteria for the medical product, the set of initial dispensing criteria being sufficient so that a responsible regulatory agency approves a change in status of the medical product to a non-prescription status for restricted distribution;
arranging the set of self-selection questions into an electronic self-selection process having an electronic self-selection algorithm related to the restricted distribution medical product on a controller of a vending machine, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the medical product and (2) information provided by a purchaser relating to the purchaser's medical condition including areas of critical interest related to the purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting, that outweighs the risks associated with not starting, treatment with the medical product;
controlling the vending machine, via the controller, to dispense a first sales unit of the restricted distribution medical product, without interaction between the purchaser and a licensed practitioner, when a purchaser successfully completes the electronic self-selection process and not to dispense the first sales unit of the restricted distribution medical product when the purchaser does not successfully completes the electronic self-selection process;
arranging the set of de-selection questions into an electronic de-selection process having a de-selection algorithm related to the restricted distribution medical product on the controller, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the purchaser relating to the purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit to continue, that outweighs the risks associated with not continuing, treatment with the restricted distribution medical product;
31. A restricted distribution medical product dispensing system, comprising:
a controller in communication with the vending machine and the one or more interface devices;
the controller configured to store an electronic self-selection process for each of the restricted distribution medical products in the storage space, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the medical product and (2) information provided by a potential purchaser relating to the potential purchaser's medical condition including areas of critical interest related to the potential purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not starting treatment,
wherein the controller is configured, upon selection of the restricted distribution medical product by the potential purchaser via the one or more interface devices, to determine whether the selection of the particular restricted distribution medical product is a first request or a second or subsequent request for the restricted distribution medical product,
wherein the controller is configured to require the potential purchaser to complete the electronic self-selection process for the first request,
wherein the controller is configured to dispense the restricted distribution medical product without interaction between the potential purchaser and a licensed practitioner, when the potential purchaser successfully completes the electronic self-selection process, and
wherein the controller is configured not to dispense the restricted distribution medical product should the potential purchaser not successfully complete the electronic self-selection process;
the controller configured to store an electronic de-selection algorithm for each of the restricted distribution medical products in the storage space, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the potential purchaser relating to the potential purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the restricted distribution medical product and, based on the evaluation, determines whether there is a benefit to continue treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not continuing treatment;
the controller configured to receive input of an unsuccessfully performed electronic de-selection process according to the electronic de-selection algorithm, for a second or subsequent purchase request for the restricted distribution medical product; and
the controller, based on the unsuccessfully performed electronic de-selection process, configured to deny the second or subsequent purchase request of the restricted distribution medical product, without intervention between the potential purchaser and a licensed practitioner, when the potential purchaser failed to successfully complete the electronic de-selection process.
32. A method of switching a behind-the-counter medical product to non-prescription, restricted distribution medical product and the dispensing of same, comprising:
selecting a medical product having a behind-the-counter status;
developing a set of initial dispensing criteria for the medical product, the set of initial dispensing criteria being sufficient so that a responsible regulatory agency approves a change in status of the medical product to nonprescription status for restricted distribution;
developing a set of self-selection questions based on the set of initial dispensing criteria;
arranging the set of self-selection questions into an electronic self-selection algorithm on a controller connected to a machine interface device of a vending machine, wherein the electronic self-selection algorithm evaluates (1) information identified by a governmental agency and included on the label of the restricted distribution medical product and (2) information provided by a purchaser relating to the purchaser's medical condition including areas of critical interest related to the purchaser's medical history and signs and symptoms of the condition to be treated and, based on the evaluation, determines whether there is a benefit of starting treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not starting treatment;
controlling the vending machine, via the controller, to dispense a first sales unit of the restricted distribution medical product, without interaction between the purchaser and a licensed practitioner, when a purchaser successfully completes the electronic self-selection process;
controlling the vending machine, via the controller, not to dispense the first sales unit of the restricted distribution medical product should the purchaser not successfully complete the electronic self-selection process;
storing an electronic de-selection algorithm on the controller for the restricted distribution medical product, wherein the electronic de-selection algorithm evaluates (1) updated information provided by the purchaser relating to the purchaser's medical condition updated to the present including different areas of critical interest from that of the electronic self-selection algorithm and (2) past use of the medical product and, based on the evaluation, determines whether there is a benefit to continue treatment with the restricted distribution medical product and whether the benefit outweighs the risks associated with not continuing treatment;
unsuccessfully performing through the controller, the electronic de-selection algorithm, for a second or subsequent purchase request for the restricted distribution medical product; and
denying by the controller based on the unsuccessfully performed electronic de-selection algorithm, the second or subsequent purchase request of the restricted distribution medical product, without intervention between the purchaser and a licensed practitioner, when the purchaser failed to successfully complete the electronic de-selection process.
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