Transmucosal Immediate Release Fentanyl (TIRF)
Risk Evaluation and Mitigation Strategy

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The TIRF REMS Access Program Privacy Statement

Descriptive. The term TRIG or 'us' or 'we' refers to the Transmucosal Immediate-Release Fentanyl ("TIRF") REMS (Risk Evaluation and Mitigation Strategy) Industry Group or its authorized representatives, the owner of the TIRF REMS Access program website. The term 'you' refers to the user or viewer of our website

Under the TIRF REMS Access program, only prescribers, pharmacies, distributors and patients enrolled in the program are able to prescribe, dispense, distribute, and receive transmucosal immediate release fentanyl (TIRF) medicines. In order for you to meet the requirements of the program, TIRF REMS Access must obtain certain Personal Information from you. The TIRF REMS Industry Group ("TRIG") and its authorized representatives are committed to respecting your privacy. Please read the following to learn more about our Privacy Policy regarding Personal Information that is collected on the website (www.TIRFREMSAccess.com).

What This Privacy Policy Covers

  • This policy covers how the TIRF REMS Access program treats personal information that the TIRF REMS Access program collects and receives through its website, including patients' health information and the personally identifiable information of anyone that registers for the training and knowledge assessment, and enrolls in the TIRF REMS Access program.

  • This policy does not apply to the practices of companies that TRIG does not own or control, or to people that TRIG companies do not employ or manage. This policy does not apply to any third party websites which may be accessed via links on the website.

Your Consent

By using the TIRF REMS Access website you agree to the terms of this REMS Website Privacy Statement. Whenever you submit information to us through the TIRF REMS Access website, you consent to the collection, use, and disclosure of that information in accordance with this REMS Website Privacy Statement, including agreeing that we may contact you through a variety of means such as email, postal mail, phone, or fax, unless you opt out of these communications by contacting us. By submitting information to TIRF REMS Access related to the REMS program, you are consenting to TIRF REMS Access using and sharing this information for any purpose consistent with the goals of the REMS program and to effectuate operation and administration of the REMS program.

Information Collection and General Use

  • The TIRF REMS Access program collects personal information when you voluntarily choose to contact us with comments or inquiries through the website or choose to use certain areas of the website, including: registering for training on the TIRF REMS Access program; registering with the TIRF REMS Access program for the Knowledge Assessment (healthcare professionals only); enrolling in the TIRF REMS Access program; requesting information from the TIRF REMS Access program; and visiting www.TIRFREMSAccess.com.

    • When you register for training (healthcare professionals only) we ask for information such as your name, email address and phone number.

    • When you enroll in the TIRF REMS Access program as a Prescriber, we ask for information such as your name, address, email address, state license and DEA number, phone and fax number and credentials. Once you enroll with the TIRF REMS Access program and log into our website, you are not anonymous to us.

    • When you enroll in the TIRF REMS Access program as a Pharmacy, we ask for information such as your name, pharmacy name and address, email address, NCPDP, NPI and DEA number, and phone and fax number. Once you enroll with the TIRF REMS Access program and log into our website, you are not anonymous to us.

    • When a prescriber enrolls a patient in the TIRF REMS Access program we will ask the prescriber for patient information such as their name, birth date, state, zip code, phone number, caregiver or representative's name and relationship to patient if applicable. The collection, use and handling of all patient information, including any Protected Health Information (PHI), will be consistent with the HIPAA (Health Insurance Portability and Accountability Act ) Authorization forms signed by the patient prior to enrolling in the TIRF REMS Access program.

  • The TIRF REMS Access program also collects information about your transactions within the TIRF REMS Access program.

  • When you interact with us through the website, the TIRF REMS Access program automatically receives and records personally non-identifiable information on our server logs from your computer, including your IP (Internet Provider) address, TIRF REMS Access cookie information, the pages you visit, and other anonymous statistical data involving your use of the website and/or the Services, but only in regard to your interactions with the TIRF REMS Access program.

    • An IP address is a number assigned to your computer for access to the Internet. All computer identification on the Internet is conducted with IP addresses, which allow computers and servers to recognize and communicate with each other.

    • The TIRF REMS Access program may set and access TIRF REMS Access non-persistent cookies on your computer. A cookie is a piece of information that is placed on your computer when you access certain Web sites. The cookie uniquely identifies your computer to the TIRF REMS Access server. Cookies allow us to store information on the server to help make the Web experience better for you and to conduct site analysis and Web site performance review. Most Web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our site may not work properly if you refuse cookies.

  • The TIRF REMS Access program uses your Personal Information to fulfill your requests for information; to verify your enrollment in the TIRF REMS Access program; conduct research related to the program; to assess compliance with the TIRF REMS Access program; and to contact you on TIRF REMS Access related matters. We use aggregated (non-personally identifiable) information to help us understand trends, website performance and patient needs. For example, we may analyze the gender or age of visitors to the TIRF REMS Access site, and we may use that analysis of aggregate data internally or share it with others such as companies that sponsor and/or support TIRF REMS Access (i.e., the manufacturers and their trusted partners) and the US Food and Drug Administration (FDA).

Information Sharing and Disclosure

  • The TIRF REMS Access program does not sell personal information about you to other people or nonaffiliated companies for any reason. Furthermore, we do not share personal information about you with other people or affiliated or nonaffiliated companies except to provide information or services you've requested, when we have your permission, or under the following circumstances:

    • We provide information to trusted business partners who work on behalf of or with the TIRF REMS Access program under confidentiality agreements. These companies may use your information to help facilitate the TIRF REMS Access program and to enable TIRF REMS Access to communicate with you about matters regarding the TIRF REMS program. These companies do not have any independent right to share or use this information.

    • We respond to subpoenas, court orders, or legal process, requests for cooperation from law enforcement or other government agencies, to establish or exercise our legal rights or defend against legal claims. In such cases, we may raise or waive any legal objection or right available to us.

    • When we believe disclosure is appropriate in connection with efforts to investigate, prevent, or take other action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, violations of the TIRF REMS Access programs Terms of Use, or as otherwise required by law;

    • We may transfer information about you if TIRF REMS Access, TRIG companies, or the business(es) that support the TIRF REMS is acquired by or merged with another company and you hereby consent to such transfer.

Notices and Bulletins.

  • Periodically, we may choose to send news, bulletins, educational materials, marketing materials, or other information to you, and will use Personal Information to send such communications.

Information Collected on this website that is NOT Covered by this Privacy Policy.

  • We may allow you to communicate with other users of the website and post information using message boards and other similar features available through the website. NONE of the information that you provide using these features is protected by this Privacy Policy. THIS PRIVACY POLICY DOES NOT APPLY TO ANY INFORMATION (INCLUDING PERSONAL INFORMATION) THAT YOU PROVIDE USING MESSAGE BOARDS OR OTHER SIMILAR FEATURES THAT MAY BE AVAILABLE THROUGH THE SITE. ALL SUCH INFORMATION IS PUBLIC INFORMATION AND MAY BE SEEN, COLLECTED OR USED BY ANYONE, INCLUDING THIRD PARTIES, NOT AFFILIATED WITH US.

Confidentiality and Security

  • We take commercially reasonable steps, including physical, electronic, and procedural safeguards, to protect Personal Information and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. However, no internet or email transmission is ever fully secure or error-free. In particular, email sent to or from the website may not be secure, and you should therefore take special care in deciding what information you send to us via email. Please keep this in mind when disclosing Personal Information to us or to any other party via the internet.

  • We limit access to personal information to employees who we believe reasonably need to come into contact with that information to in order to do their jobs and to operate the TIRF REMS Access program.

  • If you have a specific question or need to update or correct your personal information please contact us at 1-866-822-1483

  • We will notify you if a breach occurs

Visiting our website from outside the United States

  • The use and content of our website is intended for US residents. This Privacy Policy is intended to apply to collection of information from residents of the United States. If you are not a resident of the United States, please be aware that your information may be transferred to, stored and processed in the United States.

Changes to this Privacy Policy

  • TIRF REMS Access may update or modify this policy at any time. We will notify you about significant changes in the way we treat personal information by sending a notice to the primary email address specified in your TIRF REMS Access enrollment or by placing a prominent notice on our site.

Questions and Suggestions

  • If you have questions or suggestions, please contact us at 1-866-822-1483

For assistance, please call the TIRF REMS Access program at 1-866-822-1483.