Method and system for delivering substitute medical therapies with restricted access
View Patent ↗A system and methods are provided for delivering to a patient a substitute medical therapy with restricted distribution or access. One example is a medical therapy provider, such as a pharmacist, receiving a prescription for a medical therapy for a patient and describing these procedures and the substitute medical therapy to the patient. The patient and patient's prescribing physician will determine whether the proposed substitute medical therapy is desired and would be indicated for this patient, including obtaining data and informed consent from the patient. The method also provides a distributor or third party reviewer the prescription and certification from a qualified patient's physician, data and consent from a qualified patient, including an authorization for the substitute medical therapy and confirming the informed consent from a qualified patient by the distributor or a third party reviewer. From this data, the distributor or third party reviewer determines the qualified patient's eligibility for access to the medical therapy and, if the qualified patient is found eligible, delivers the medical therapy to the patient.
1. A method executed by a computer processor for providing restricted access to a generic drug by a medical therapy provider comprising:
a pharmacy receiving a prescription for a patient for a branded restricted distribution drug prescribed by a physician, wherein the prescription has been previously approved for fulfillment, and wherein a branded restricted distribution drug is a drug that requires compliance with a Food and Drug Administration (FDA)-approved risk management program;
the pharmacy determining that a generic drug is available as a substitute for the branded restricted distribution drug;
the pharmacy contacting a manufacturer of a generic drug available as a substitute for the branded distribution drug;
the generic drug manufacturer:
determining the eligibility of the patient for the generic drug in compliance with an FDA-approved drug risk management program for the generic drug;
obtaining approval, if necessary, from the prescribing physician to substitute the generic drug for the branded distribution drug;
authorizing the fulfillment of the generic drug to the patient only after determining that the patient is eligible and, if necessary, after obtaining the approval from the prescribing physician to substitute the generic drug for the branded restricted distribution drug, wherein the fulfillment may be provided by one of: the pharmacy, the prescribing physician, the generic drug manufacturer, or a distributor, and wherein the distribution of the generic drug is not authorized if the patient is determined to be ineligible;
after authorizing the fulfillment of the generic drug to the patient, recording data associated with the patient, the eligibility determination of the patient for the generic drug, and the fulfillment of the generic drug in a computer-readable medium; and
wherein the authorizing the fulfillment of the generic drug to the patient does not comprise:
the generic drug manufacturer or distributor generating a prescription approval code prior to fulfillment of the prescription; or
requiring the patient, the pharmacy, or the prescribing physician to be registered with the generic drug manufacturer or distributor prior to the fulfillment of the prescription.
2. The method of claim 1 , wherein the generic drug is a product with the potential for substance abuse or chemical dependence.
3. The method of claim 1 , wherein the generic drug requires ongoing diagnostic testing for continued therapy.
4. The method of claim 1 , wherein the generic drug is thalidomide.
5. The method of claim 1 , wherein the generic drug is lenalidomide.
6. The method of claim 1 , wherein the generic drug is isotretinoin.
7. The method of claim 1 , wherein the generic drug is bosentan.
8. The method of claim 1 , wherein the generic drug is alosetron.
9. The method of claim 1 , wherein the generic drug is dofetilide.
10. The method of claim 1 , wherein the generic drug is oxycodone.
11. The method of claim 1 , wherein the generic drug is cannabis.
12. The method of claim 1 , wherein the generic drug is clozapine.
13. A method executed by a computer processor for providing restricted access to a generic drug by a generic drug manufacturer or distributor comprising:
receiving a request for distribution of the generic drug for a specific patient, wherein the prescription has been previously approved for fulfillment as a branded restricted distribution drug prescribed by a physician, and wherein a branded restricted distribution drug is a drug that requires compliance with a Food and Drug Administration (FDA)-approved risk management program;
obtaining relevant risk-assessment documents from the prescriber who originated the request for the patient;
the generic drug manufacturer or distributor:
determining the eligibility of the patient for the generic drug in compliance with an FDA-approved drug risk management program for the generic drug;
obtaining approval, if necessary, from the prescribing physician to substitute the generic drug for the branded distribution drug;
facilitating access of the generic drug to the patient only after determining that the patient is eligible, and wherein the distribution of the generic drug is not facilitated if the patient is determined to be ineligible;
after facilitating access of the generic drug to the patient, recording data associated with the prescription, the eligibility determination of the patient for the generic drug, and the generic drug provided in a computer-readable medium; and
wherein the facilitating access of the generic drug to the patient does not comprise:
the generic drug manufacturer or distributor generating a prescription approval code prior to providing the generic drug; or
requiring the patient, the pharmacy, or the prescribing physician to be registered with the generic drug manufacturer or distributor prior to providing the generic drug.
14. The method of claim 13 , wherein the generic drug is a product with the potential for substance abuse or chemical dependence.
15. The method of claim 13 , wherein the generic drug requires ongoing diagnostic testing for continued therapy.
16. The method of claim 13 , wherein the generic drug is thalidomide.
17. The method of claim 13 , wherein the generic drug is lenalidomide.
18. The method of claim 13 , wherein the generic drug is isotretinoin.
19. The method of claim 13 , wherein the generic drug is bosentan.
20. The method of claim 13 , wherein the generic drug is alosetron.
21. The method of claim 13 , wherein the generic drug is dofetilide.
22. The method of claim 13 , wherein the generic drug is oxycodone.
23. The method of claim 13 , wherein the generic drug is cannabis.
24. The method of claim 13 , wherein the generic drug is clozapine.
25. A method executed by a computer processor for delivering a substitute medical therapy product comprising:
receiving a prescription for a patient for a branded restricted distribution medical therapy prescribed by a physician, wherein the prescription has been previously approved for fulfillment, and wherein a branded restricted distribution medical therapy is a medical therapy that requires compliance with a Food and Drug Administration (FDA)-approved risk management program;
determining that a substitute medical therapy is available as a substitute for the branded restricted distribution drug;
describing features to obtain the substitute medical therapy for a qualifying patient for whom the branded medical therapy is prescribed;
contacting a manufacturer of a substitute medical therapy available as a substitute for the branded medical therapy;
the substitute therapy manufacturer:
obtaining data and patient's informed consent to receive the substitute medical therapy for the branded medical therapy,
wherein the consent includes an authorization to release the patient's medical records to deliver the substitute medical therapy;
providing, to the distributor of the substitute medical therapy, the authorization, certification data, informed consent and required diagnostic tests,
wherein the certification data includes conclusions from the prescribing physician that the patient is a qualified patient for the substitute medical therapy and representations that the prescribing physician will follow the requirements of the restricted access program for the substitute medical therapy;
confirming the informed consent from the qualified patient to the distributor of the substitute medical therapy;
determining the eligibility of the patient for the substitute medical therapy by the distributor of the substitute medical therapy in compliance with an FDA-approved drug risk management program for the substitute medical therapy;
obtaining approval, if necessary, from the prescribing physician to substitute the substitute medical therapy for the branded medical therapy;
delivering the substitute medical therapy to the eligible patient only after the distributor of the substitute medical therapy determining that the patient is eligible, and wherein the distribution of the substitute medical therapy is not authorized if the patient is determined to be ineligible;
after delivering the substitute medical therapy to the patient, recording data associated with the prescription, patient, the eligibility determination of the patient for the substitute medical therapy, and the delivery of the substitute medical therapy in a computer-readable medium; and
wherein the delivery of the substitute medical therapy does not comprise:
the substitute medical therapy manufacturer or distributor generating a prescription approval code prior to delivering the substitute medical therapy; or
requiring the patient, the pharmacy, or the prescribing physician to be registered with the substitute medical therapy manufacturer or distributor prior to the delivery of the substitute medical therapy.
26. The method of claim 25 , further comprising:
obtaining data regarding a procedure for delivering a substitute medical therapy.
27. The method of claim 25 , further comprising:
confirming and recording prescription data including the prescription label.
28. The method of claim 25 , further comprising:
obtaining additional data from the qualified patient to determine present or future qualification or eligibility for the substitute medical therapy.
29. The method of claim 25 , wherein the substitute medical therapy is a product with the potential for substance abuse or chemical dependence.
30. The method of claim 25 , wherein the substitute medical therapy requires ongoing diagnostic testing for continued therapy.
31. The method of claim 25 , wherein the substitute medical therapy is thalidomide.
32. The method of claim 25 , wherein the substitute medical therapy is lenalidomide.
33. The method of claim 25 , wherein the substitute medical therapy is isotretinoin.
34. The method of claim 25 , wherein the substitute medical therapy is bosentan.
35. The method of claim 25 , wherein the substitute medical therapy is alosetron.
36. The method of claim 25 , wherein the substitute medical therapy is dofetilide.
37. The method of claim 25 , wherein the substitute medical therapy is oxycodone.
38. The method of claim 25 , wherein the substitute medical therapy is cannabis.
39. The method of claim 25 , wherein the substitute medical therapy is clozapine.
40. The method of claim 25 , further comprising:
obtaining additional data from the qualified patient for quality control.