Celgene REMS Programs Software User Guide

Transcription

1 Celgene REMS Programs Software User Guide

2 Table of Contents Overview and Warnings 4 CD Installation 5 Web Installation 5 Windows users 6 Windows CD Installation 6 Windows Web Installation 6 Windows Program Installation Process 7 Mac users 8 Mac CD Installation 8 Mac Web Installation 8 Mac Program Installation Process 8 Generating the Patient-Physician Agreement Forms 10 Generating the Patient Prescription Form 12 Frequently Asked Questions 14 Windows is a registered trademark of Microsoft Corporation in the United States and other countries. Macintosh, Mac, and Mac OS are trademarks of Apple Computer, Inc., registered in the U.S. and other countries. 2 3

3 Overview Use this guide for detailed instructions on how to install and generate software for the Celgene REMS programs. After installation you will be able to: Enroll patients Access Patient-Physician Agreement Forms Access Patient Prescription forms Please be sure to read through the important warnings listed below. Important Warnings 1. Do not uninstall the existing versions of the REMS program(s) before installing the upgrade. Uninstalling the program(s) will delete all patient and prescriber data. To migrate existing patient and prescriber information, the program(s) must be installed on the same computer as the existing software. 2. After installing the new versions of the REMS program(s), do not reinstall the old versions of the software(s). Reinstalling the old versions of the software will not allow your patient and prescriber data to migrate to the new versions. 3. Do not install the programs on a network server. If the previous version is stored on the network, STOP and contact your Celgene Hematology Oncology Consultant. 4. Close all Celgene REMS programs when not in use, or while installing or uninstalling any Celgene REMS programs. 5. After installation, do not copy Celgene REMS files or folders to new locations. Additionally, do not edit any Celgene REMS file or folder names after installation. 6. Do not manually delete the Celgene REMS programs. Always use the included uninstaller to remove any Celgene REMS programs. Warning: Uninstalling the program will erase all patient and prescriber data. See the FAQs section on page 14 for answers to questions that may arise during the installation process. If those questions are not answered, please contact your Celgene Hematology Oncology Consultant. Please ensure the computer has the minimum system requirements needed before installing the program(s) on a Windows or Mac computer. Follow the appropriate section below to get started with a CD or Web installation before proceeding to the Program Installation Process. CD Installation Minimum System Requirements for Windows All versions of Microsoft Windows 2000, XP (Service Pack-3), Vista, Windows MB free hard disk space CD-ROM drive Screen Resolution: 1024 x 768 Web Installation Minimum System Requirements for Windows All versions of Microsoft Windows 2000, XP (Service Pack-3), Vista, Windows MB free hard disk space Active internet connection for installation Web Browser Screen Resolution: 1024 x 768 Minimum System Requirements for Macintosh Mac OS 10.2 or greater Service Pack 500 MB free hard disk space CD-ROM drive Screen Resolution: 1024 x 768 Minimum System Requirements for Macintosh Mac OS 10.2 or greater Service Pack 500 MB free hard disk space Active internet connection for installation Web Browser Screen Resolution: 1024 x 768 TIP: Make sure all other windows and programs are closed prior to beginning the installation, as some systems require the computer to be restarted after the installation is complete. In addition, some programs may interfere with the installation process. 4 5

4 Windows Users Windows CD Installation 1. Insert the disk into the CD-ROM drive to begin the installation. 2. Click Start. 3. Click Run. The Run dialogue box appears. 4. In the open box, type D:\SETUP.EXE or replace D with your computer s CD-ROM drive name. Note: The installer will automatically detect if you have a 32-bit or 64-bit Operating System, and will run the correct installer version. Installing the wrong version may cause the Celgene REMS program(s) to not function properly. 5. Click OK to begin the installation process. Refer to the Windows Program Installation Process section to continue with the installation of the program(s). Windows Web Installation 1. Open a Web Browser, and type the URL/website address in the address box. 2. Click the download REMS Programs link. Note: The Celgene REMS programs are available in 32-bit and 64-bit versions. Please ensure to install the correct version of the Celgene REMS program(s) depending on your operating system. Installing the wrong version may cause the Celgene REMS program(s) to not function properly. If you are unsure of the version to install, please reference this table as a guideline: 32-bit Operating Systems Microsoft Windows bit Operating Systems Microsoft Windows Vista Windows Program Installation Process 1. Check the checkboxes of the program(s) to install. 2. Click Next. 3. Select the location for where to save the program(s). The Default Location is C:\Program Files\Celgene. 4. Click Next. 5. If an existing version of the program(s) is installed on the computer, ensure the check box is checked to migrate the existing patient and prescriber data to the new installation. Note: It is highly recommended that all existing patient and prescriber data be migrated to the new installation. All existing program(s) will be deleted from the computer upon finishing the installation. 6. Click Next. Note: If the checkbox is not checked, a warning will be displayed to confirm beginning the installation without migrating the existing data. Click the Continue button to proceed with the installation, or click Cancel to return to the current page. 7. Click Next to begin the installation. 8. Click Finish to complete the installation. 9. A restart of the computer may be required depending on the operating system. If a Restart Computer window is displayed, click Yes to restart the computer, or No to postpone the restart. Note: If you are updating from a previous installation, existing shortcut links will be broken after the upgrade. Please refer to the FAQs section on page 14 for more details. Microsoft Windows XP (Service Pack-3) Microsoft Windows 7 Microsoft Windows Server 3. Depending on the operating system, a security warning may be displayed. Click Yes to continue. 4. Click Run. Refer to the Windows Program Installation Process section to continue with the installation of the program(s). 6 7

5 Mac Users Mac CD Installation 1. Insert the disk into the CD-ROM drive to begin the installation. 2. Double-click the Celgene disk icon that displays on the desktop. 3. Double-click the Mac_OS directory. 4. Double-click the Setup_macos file. 5. Double-click the Celgene REMS Programs Installer file to begin the installation process. Refer to the Mac Program Installation Process section to continue with the installation of the program(s). Mac Web Installation 1. Open a Web Browser, and type the URL/website address in the address box. 2. Select the download REMS Programs link. 3. Depending on the operating system, a security warning may be displayed. Click Yes to continue. 4. Click Run. Refer to the Mac Program Installation Process section to continue with the installation of the program(s). Mac Program Installation Process 1. Check the checkboxes of the program(s) to install. 2. Click Next. 3. Select the location for where to save the program(s). The Default Location is /Applications/Celgene. 4. Click Next. 5. If existing versions of the software are installed on the computer, check the checkboxes of the existing programs that must migrate the existing patient and prescriber data to the new versions. If you do not wish to migrate the data, do not check the checkboxes. Note: It is highly recommended that all existing patient and prescriber data be migrated to the new installation. All existing program(s) may be deleted from the computer upon finishing the installation. 6. Click Next. Note: If the checkboxes are not checked, a warning will be displayed to confirm beginning the installation without migrating the existing data. Click the Continue button to proceed with the installation, or click Cancel to return to the current page. 7. If any checkboxes are checked to migrate the data, the installer will attempt to auto-detect the existing software location. If the installer locates the existing software, the location will be populated in the Browse box. If the installer is not able to auto-detect the existing software, the existing version must be manually selected by clicking the Browse button and selecting the location. Please note the software must be selected at the specific program folder. Note: If an existing location is not selected for a program, the installer will not be able to migrate the existing data. Please ensure the existing locations are selected for all programs to be migrated. If you do not wish to migrate a program, click the Back button and uncheck the checkboxes of the programs you do not wish to migrate. 8. Click Next. 9. Click Next to begin the installation. 10. Click Finish to complete the installation. 11. A restart of the computer may be required depending on the operating system. If a Restart Computer window is displayed, select Yes to restart the computer, or No to postpone the restart. Note: If you are updating from a previous installation, existing shortcut links will be broken after the upgrade. Please refer to the FAQs section on page 14 for more details. 8 9

6 Generating the Patient-Physician Agreement Forms This section explains the process of generating the most appropriate of the 6 Patient-Physician Agreement Forms that corresponds to the specific patient s demographic. In this process, patient and prescriber information is entered into the Patient and Prescriber sections in the Patient-Physician Agreement Form screen. Data from the Patient and Prescriber sections are then copied into the applicable Patient-Physician Agreement Form. To generate the Patient-Physician Agreement Form: 1. Windows users: Click Start. Move the cursor until Programs is highlighted, choose the Celgene folder, choose the REMS folder, choose REMS Program, and click once. Macintosh users: Click the Finder icon and navigate to the REMS folder (Applications/Celgene/REMS). Double-click on the REMS icon. 2. The REMS logo screen will be displayed. Click on the ENROLL PATIENT button. The Patient-Physician Agreement Form screen appears 3. Enter information into each of the fields in the Patient Information section located in the upper portion of the Patient-Physician Agreement Form screen. Note that instructions for each field are displayed at the bottom of the screen, and that: When typing in the year in the DOB field, all 4 digits are required The Date field automatically fills in the current date The diagnosis can be filled in with the appropriate code by pressing F2 when the cursor is placed in the Diagnosis field. Pressing F2 displays the Diagnosis Code Search screen. (To use the F2 key on a Macintosh, hold down the fn key and the F2 key at the same time). The appropriate diagnosis can then be highlighted and transferred to the Diagnosis field on the Patient-Physician Agreement Form screen by clicking Accept If the patient is female, select the appropriate values for the menstruation, surgical menopause, and natural menopause fields Complete all the required Prescriber Information fields in the lower portion of the Patient-Physician Agreement Form screen The personal information for each prescriber needs to be entered only once. To generate subsequent forms for a prescriber, put your cursor in the prescriber Last Name field and press F2 A list of previously entered prescribers will appear After highlighting a name, click OK to import that data into the Patient-Physician Agreement Form Prescribers may be added to this list by clicking Add. Prescriber s records may be modified (eg, name change) by clicking Modify To add more addresses for a prescriber, put your cursor in the prescriber Street field and press F2 A list of previously entered prescribers will appear After highlighting a name, click OK to import that data into the Patient-Physician Agreement Form Note: After enrolling your first patient, use the same address in the Prescriber Information section if you are enrolling additional patients out of the same office. 4. The Patient-Physician Agreement Form will be automatically saved when submitted. Files may be saved manually by selecting Save from the File menu To retrieve the information at another time, press F2 from the patient s Last Name field or select Open from the File menu, select the previously saved file, and either double-click the entry or click OK The information for each patient needs to be entered only once. To access a patient s information from a completed form, open a new Patient-Physician Agreement Form, place your cursor in the Last Name field, and press F2 or select Open from the File menu. A list of previously entered patients will appear Select the desired patient file, and either double-click the entry or click OK. Both the patient information and the information for the patient s prescriber will be imported into the Patient-Physician Agreement Form 5. When the Patient-Physician Agreement Form screen is complete, click OK. 6. The Patient-Physician Agreement Form displays. 7. Print the Patient-Physician Agreement Form. Select Print from the File menu or click Print. Note that the patient and the prescriber information previously entered into the Patient-Physician Agreement Form screen has been copied into the form. Now inspect the form for accuracy and completeness. At this point, the process of generating the Patient-Physician Agreement Form is complete

7 Generating the Patient Prescription Form This section explains the process of generating a Patient Prescription Form for use at a pharmacy that distributes the treatment. In this process, an enrolled patient s information is loaded into the Patient Prescription Form screens and further information is entered about the patient, the prescriber, and the prescription. Data from these sections are then copied into the Patient Prescription Form. This form is printed, signed, and dated by the prescriber, then faxed to the pharmacist, where the prescription is filled and confirmed with Celgene. Note: Refrain from writing extraneous handwritten material on the form other than the prescriber s signature. To generate the Patient Prescription Form: 1. After you have finished with the print preview for the Patient-Physician Agreement Form, you will automatically be prompted to write a prescription for the patient. Alternately, you can open the REMS Program again and click WRITE PRESCRIPTION You will be prompted to choose a patient from the list For a new patient, select new from the patient list 2. The software then displays the first screen of the Patient Prescription Form. Most of the information will be filled in automatically from the record of the enrolled patient. Enter missing information into the required fields or by using the pull-down menus. Note that instructions for each field are displayed at the bottom of the screen, and that Date Rx Needed and Language Preference are required Patient Allergies and Other Current Medications are required 3. After all information is entered on the first page, click Next. 4. The second screen of the Patient Prescription Form is displayed. Enter required information about the prescriber, including Prescriber State License Number, Prescriber Last Name, Prescriber First Name, and Prescriber Phone Number This screen also contains space for information about Primary and Secondary Insurance 5. After all information is entered on the second page, click Next. 6. The Patient Prescription screen is displayed. Check the box that corresponds to the Dose in milligram (mg) strength and enter the Quantity of capsules Fill in the medication Directions in the space provided. Be sure to select the correct choice of either Dispense as Written or Substitution Permitted, which will be indicated on the completed form for the pharmacist Finally, enter the Authorization Number obtained from Celgene Customer Care Center 7. When you are finished with these three screens, press Print. 8. The Patient Prescription Form print preview window appears. The Patient Prescription Form is now filled out with data collected on the previous screens. 9. Print the Patient Prescription Form. Select Print from the File menu or click Print. Check the printed form for accuracy and completeness At this point, the procedure for generating the Patient Prescription Form is complete

8 Frequently Asked Questions 1. What if I only want to install one or two programs? The installation process allows for the installation of individual or multiple programs concurrently. It is up to the user s discretion how many programs to install. 2. If only one program is installed initially, can the other two programs be installed later? Yes. If only one program was selected during the initial installation, the user can install additional program(s) later. To do so, follow the steps below in the Program Installation Process. At the program setup screen, only select the additional program(s) to be installed, and follow the screen prompts to complete the installation. Note: Only the program(s) not installed during the previous install need to be selected. 3. Can the program(s) be installed to multiple computers or hosted on a network drive? What if the existing program(s) are installed on a network drive? The program(s) can be installed on multiple computers, but is not recommended for installation on a network server. Note: If the existing program(s) are installed on a network drive, STOP. Do not proceed with the installation, and please contact your Celgene Hematology Oncology Consultant for more information. 4. What should I do if an error message appears when I try to install the program(s)? Please contact your Celgene Hematology Oncology Consultant. 7. What should I do if the patient and prescriber information from the previous version of the REMS software is not accessible after the upgrade? The Celgene REMS installation process allows for existing patient and prescriber data to be migrated to the new version(s). While installing the new Celgene REMS program(s), please ensure to opt in for migrating any existing patient and prescriber data to the new version(s). Note: All existing patient and prescriber data will be lost if it is not migrated to the new Celgene REMS program(s). Please ensure to migrate any patient and prescriber data to the new version(s). 8. What is wrong if the Patient or prescriber information entered in one Celgene REMS program cannot be accessed in the other Celgene REMS programs? Patient and prescriber information in one program is not shared across multiple programs. 9. Is my patient s data entered in the program(s) encrypted? Yes, all patient and prescriber data is encrypted in the program(s). 10. What should I do if the program shortcut link does not work after the upgrade? The shortcut link will be broken after the upgrade. Delete the old link from the desktop and create a new link according to your operating system. 5. What should I do if a prompt appears requesting Administrator rights for installation? Please contact your system administrator or your IT support group. 6. What should I do if the computer does not have a CD-ROM drive? If the computer does not have a CD-ROM drive, please contact your Celgene Hematology Oncology Consultant

9 2013 Celgene Corporation 8/13 REMS-GEN13312