I am providing information about my patient to Vanda Pharmaceuticals Inc. (“Vanda”), including Vanda’s HETLIOZSolutions™ Program operated by RxC Acquisition Company d/b/a RxCrossroads, and/or any other entity that subsequently operates the HETLIOZSolutions™ Program on behalf of Vanda (collectively “the Entities”) on the HETLIOZSolutions™ Prescription & Service Request Form for the purposes set forth on that form with the understanding that, with respect to any protected health information of my patient, the Entities agree to do the following, in compliance with the requirements imposed on business associates in 45 CFR Parts 160 and 164:
|(a)||Not use or disclose protected health information other than as permitted or required in the HETLIOZSolutions™ Prescription & Service Request Form or as required by law;|
|(b)||Use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided herein;|
|(c)||Report to me any use or disclosure of protected health information not provided for herein of which the Entities becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which the Entities becomes aware;|
|(d)||In accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the Entities agree to the same restrictions, conditions, and requirements that apply to the Entities with respect to such information;|
|(e)||Make available protected health information in a designated record set to me as necessary to satisfy my obligations under 45 CFR 164.524;|
|(f)||Make any amendment(s) to protected health information in a designated record set as directed or agreed to by me pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy my obligations under 45 CFR 164.526;|
|(g)||Maintain and make available to me the information required to provide an accounting of disclosures as necessary to satisfy my obligations under 45 CFR 164.528;|
|(h)||To the extent the Entities are to carry out one or more of my obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to me in the performance of such obligation(s); and|
|(i)||Make their internal practices, books, and records available to the Secretary of the Department of Health and Human Services for purposes of determining compliance with the HIPAA Rules.|
|(j)||Use or disclose protected health information only as set forth in the HETLIOZSolutions™ Prescription & Service Request Form and only to the extent of the minimum information necessary to accomplish the purpose of the use or disclosure or to de-identify the information in accordance with 45 CFR 164.514(a)-(c).|
|(k)||In the event I elect to terminate my participation in the HETLIOZSolutions™ Program (which I may do at any time by notifying the Entities in writing), return or destroy all protected health information they received from me, provided such return or destruction is feasible. If return or destruction is infeasible, the Entities will extend the protections of this agreement to the information for as long as the Entities hold the information.|
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQTM oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.
Please see full US Prescribing Information.