REMS Portal Training page

VIDEO GUIDE

JYNARQUE^® (tolvaptan) REMS Portal

The REMS Portal offers useful tools for both Prescribers and Office Liaisons. Navigate through the chapters of this video guide by using the tabs below the video.

Below the video are answers to several frequently asked questions, which can also be found throughout the video. Press play or choose the chapter you’d like to start with to learn more about the REMS Portal.

Looking to learn about a specific topic?

Select a topic below to jump to the relevant portion of the video

AE=adverse event; PFS=Patient Status Form

Frequently Asked Questions

If I forget my login password, how can I reset it?

Click on the “Forgot Password” link at the login prompt. You will receive an email containing a temporary password that is valid for 7 days, which can be used to change your password. If a password is expired, please contact REMS Coordinating Center at 1-866-244-9446 (phone) or 1-866-750-6820 (fax), M–F 8:00 am–8:00 pm ET. Passwords expire every 180 days.

When trying to log into the REMS Portal, I was asked to enter my phone number or a six-digit code. What should I do?

When logging in using your username and password for the first time, you will be prompted to register and enter a phone number to receive a six-digit code via text message for securing your logins.
Once you’ve received the code, click the “Continue” button to enter the code, then click “Continue” again to successfully log in.
For subsequent logins, you will automatically receive a six-digit code via text message to your registered phone number. Enter the code and click the “Continue” button to successfully log in.
If the Office Liaison or Provider does not have a cell phone or have access to their cell phone during the day, they also have the option to receive a code via voice call to their selected telephone number.

Can I reactivate a patient that has discontinued their JYNARQUE treatment?

If the patient has discontinued JYNARQUE less than 1 year ago, they can be reactivated via the "Reactivate Patient" button associated with their profile in the REMS Portal. If they discontinued JYNARQUE over 1 year ago, a new REMS Patient Enrollment Form will be required and the reactivate button cannot be utilized.

What steps are required when a patient is deactivated?

When a prescriber selects the "Deactivate Patient" button, the specialty pharmacy must be notified of the discontinuation of therapy. Similarly, the Prescriber should also alert the REMS Coordinating Center either via the deactivate button in the portal or by contacting REMS Coordinating Center at 1-866-244-9446.

A patient can only be deactivated by manual request from the office, or via the portal, and will not automatically be deactivated. Deactivated patients will remain in the portal, but can be filtered out of the patient list view under the Status column.

By deactivating the patient, the prescriber will no longer receive requests via email or portal to complete PSF submissions.

When enrolling an Office Liaison, what information is needed by REMS Coordinating Center?

An Office Liaison can contact REMS Coordinating Center at 1-866-244-9446 to enroll themselves and must provide their email address, the Prescriber’s name and address, or their NPI.

What is the procedure when using the REMS Portal for transferred patients?

When patient care is transferred to a new Prescriber, a phone call must be made to REMS Coordinating Center at 1-866-244-9446 to associate the patient with the new Prescriber. The transferred patient will appear in the Prescriber and Office Liaison portals within 24 hours. Please contact the specialty pharmacy to notify about the transfer.

How can I update my information in the REMS Portal?

Prescribers may update information such as their contact information and their preferred communication method by editing the information in the My Profile section of the REMS Portal.

How can I update an Office Liaison’s contact information in the REMS Portal?

Office Liaison contact information can be updated in the Office Liaison Management section of the Prescriber REMS Portal. Click the pencil icon to edit the Office Liaison’s information. Please remember to remove any Office Liaisons who are no longer associated with your office.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

September 2023

22US23EBP0073

Otsuka Patient Support™ Health Information Use and
Disclosure Authorization (“Authorization”)

Permission to Use and Disclose Health Information: This Authorization relates to the Otsuka Patient Experience Program and patient experience team. The Program provides services relating to drugs and devices ("Products") of OPH Inc. and its affiliates and successors ("Otsuka"). Your "Providers," for purposes of this Authorization, include any physician, pharmacy, care center, clinic, or other healthcare facilities and professionals, as well as any discount plan, health plan, or other payors that may have information related to the Products you use. By signing this Authorization, you (or your personal representative on your behalf) allow your Providers and Otsuka, along with the Recipients defined below, to use and disclose some of your Protected Health Information as defined below ("PHI") and as described in this Authorization.

PHI Recipients: Your Providers may give your PHI to Otsuka and any Program operators, manufacturers and distributors of the Product, and contractors ("Recipients"). The Recipients can also re-disclose your information to their contractors, vendors, and third parties that may take over the Program in the future. For example, Otsuka may give your information to vendors, advocacy organizations, patient assistance programs, patient access centers, data aggregators, laboratories, safety program administrators, Otsuka Digital Health, other business partners, website tracking tool vendors, and personnel of these third parties. For purposes of this Authorization, “Recipients” include Otsuka and all of these other third parties. “Recipients” also include any legal representatives, caregivers or other contacts listed in this Authorization.

PHI to be Used and Disclosed: PHI includes any and all health information related to the following:

Your name, address, patient ID number, and other demographic data, date of birth, and information you provide on any forms related to the Products
Healthcare records related to your eligibility for and use of the Products, such as dates of treatment, dosage, and dispensing
The healthcare condition for which the Products were or may be prescribed, or your condition while taking or after stopping the Products. You understand that this may include sensitive PHI
Your experience with the Products, including whether you take them as prescribed
Health coverage, financial, payment, and claim information related to the Product or your ability to pay
Information to help support your transition of care, such as getting discharged from a hospital

Purposes: The Recipients may use, share, and re-disclose your PHI, in electronic or any other form or format, for the following purposes:

Determining if you qualify for and contacting you about the Program and Product-related services
Providing assistance to you regarding the Product, facilitating access to the Product, determining health plan coverage requirements, and communicating with you and the Providers regarding the Product, your treatment, or payment for the Product
Internal data collection, research, and reporting, including reviewing utilization, trends, and future needs of patients and providers
Data analysis including de-identifying the PHI, creating limited data sets, or combining it with other information, and monetizing de-identified data as permitted by law
Establishing your treatment profile, tracking coverage, and determining cost sharing
Examining the effectiveness and operation of the Program
Analysis to help evaluate and improve the Program and create new programs
Consistent with applicable law and any applicable standards of ethical conduct, contacting your healthcare provider(s), law enforcement, emergency services, a family member, or any other person reasonably able to assist if a Recipient has a good faith belief that such action is necessary to prevent or lessen a threat to your health or safety, or to the health and safety of others
Fulfilling the Recipients' legal obligations
Using tracking tools on websites and applications to examine your interaction and experience with Program-related or Product-related platforms and to help the websites and applications function
Proper management and administration of the Recipients and the Program, including re-disclosures to other Recipients, Providers, payors, and service providers as needed to operate the Program

Revocation: You may revoke and cancel this Authorization by calling 1-833-468-7852 emailing [email protected], or sending a written notice to Otsuka Patient Support™, 508 Carnegie Center Drive, Princeton, NJ 08540. If you have questions about the Program, you can talk to your Provider and/or call Otsuka Patient Support™ at that number. If a Provider is disclosing PHI for the Program on an ongoing basis, your revocation will take effect with respect to such Provider when they receive notice of your revocation. Revocation will not affect any uses or disclosures of PHI that took place before such cancellation was received. For example, if your PHI has already been shared with third parties, it will not be able to be deleted. If you revoke this Authorization you will no longer be eligible to receive Program services, but this will not affect your ability to receive the Product.

Voluntary Authorization: You do not have to sign this Authorization. Refusal to sign will not affect the start, continuation, or quality of your treatment or any other treatment, payment, enrollment in health plans, or eligibility for benefits for which you qualify. Your Providers may not condition treatment, payment, enrollment, or eligibility for benefits on whether you sign this Authorization.

Re-Disclosure: Once your PHI is disclosed as allowed in this Authorization, it may be re-disclosed by the Recipients and will no longer be protected by the Health Insurance Portability and Accountability Act (HIPAA). Additionally, it may no longer be protected by certain other state and federal privacy and security laws.

Expiration: This Authorization will remain in effect for one (1) year from the date of the signature(s) below or until it is revoked, whichever is earlier.

Copy of Authorization: You have a right to receive a copy of this authorization.

By signing this Authorization, you acknowledge that you have read and understand this Authorization and expressly authorize the uses and disclosures of PHI referenced in this Authorization.

Consent: By signing this Authorization, I acknowledge and confirm that I have read, understand, and agree to this Authorization and expressly authorize the uses and disclosures of PHI referenced in this Authorization.

Individuals signing electronically: By signing this Authorization electronically, you understand that you will receive a copy of your completed Authorization to the email address that you provide. You must let us know if your email or other contact information changes. You understand that your email system may not be a completely secure form of transmission and is not always encrypted. You understand that you may sign a hard copy of this form if you prefer not to sign electronically.

JYNARQUE® (tolvaptan) REMS Portal