Risk Management Programme (RMP) UK & Ireland electronic Prescription Authorisation Form (epaf) User Guide
1. RMP UK & Ireland - epaf Prescriber Self-registering in the epaf system
1.1 Starting self-registration process You will need to register to use the epaf system. Browse to epaf UK & Ireland website https://ermpukire.celgene.com On the login screen select Register link to start selfregistration process
1.2 Self-registration Select Prescriber from the User type drop-down box then click Next Select relevant country from the Country drop-down box then click Next Fill in Contact Information then click Next A validation button will appear when you have entered all your details including your GMC number. This performs a check with a third-party provider and is optional at this point. The validation will happen automatically when you click Register
1.3 Self-registration & first-time login Upon completion you will receive an email with a temporary password Navigate to the login page and enter your email address and the temporary password to login for the first time
1.4 First time login security settings After logging in for the first time you will be prompted to change your password and select a security question and answer
1.5 Confirm PPP documents Once the password is changed you will be prompted to download and accept the Pregnancy Prevention Programme documents The documents you are prompted to download are dependent on the products handled at the institution(s) you are linked to This prompt will be also be displayed if new versions of the PPP documents are available in the system You will be also be prompted to download and accept the PPP documents after 2 years as per the PPP regulations
2. RMP UK & Ireland - epaf Prescriber Landing Page and New Patient Registration
2.1 Landing Page elements The Register Patient link allows you to register a new patient and create the very first epaf The Search Patients link redirects you to a list of patients in the relevant Institution The Manage epafs top navigation link takes you to a list of epafs for the relevant Institution
2.2 New Patient registration From the landing page select Register Patient to start the process Fill in the patient details DO NOT USE Pending label change - PLEASE DO NOT ENTER A PATIENT S NHS NUMBER Click Next to proceed
2.3 New Patient registration & first epaf Check the Patient details are correct Add the prescription creation date in the Prescription general information section In the Treatment Information section Select appropriate Product from the dropdown Select the Risk Category Tick Is private patient if appropriate Tick Home care if the Patient is receiving Home care services The Product and Risk Category selection determines which checklist will be displayed Click on Download PIC (Patient Informed Consent form) and print it off; paper forms can be used if no printer available but form still needs downloading Confirm PIC has been printed and signed by the Patient Tick Checklist box for the relevant Risk Category; please note there is no checklist for the WNCBP Category Click Next to proceed
2.4 New Patient registration & first epaf Check the patient details are correct In the Treatment Information section Check the Product selection Choose the relevant Indication Choose the relevant Treatment Stage In the Cycles section Use Add cycle button to add Treatment Cycle Click red cross icon to remove Treatment Cycle if required
2.5 New Patient registration & first epaf Use Add prescription line link to display the prescription line pop up Select the relevant Pack Quantity of Packs Frequency of receiving the drug Click Add to add the line details to the Treatment Cycle In the Pharmacies section choose the Pharmacy that this Prescription should go to Confirm your identity by entering your password; this is your signature authorising the epaf Click on Submit to send the epaf to the pharmacy
2.6 New Patient registration print-out Once you have registered a patient you have the option to print the content of the PIC and epaf for your records
3. RMP UK & Ireland - epaf Prescriber Accessing the epaf system
3.1 Accessing the epaf System You can access the epaf system using any of the following browsers Internet Explorer versions 7 and newer Firefox Chrome Safari Use the URL https://ermp-ukire.celgene.com, then enter your email address and password to access the system
3.2 Accessing the epaf System After the PPP documents are accepted you will see a pop-up window to allow you to choose your current Institution from those you selected during the registration process Every further action in the system will be executed in the context of the Institution chosen at login
4. RMP UK & Ireland - epaf Prescriber Landing Page and Existing Patient epaf Creation
4.1 Prescriber Landing Page overview The Patient List shows a list of patients relevant to the current Institution The Actions column allow you to: add a prescription edit patient data view patient data The Column headers allow you to filter and sort data
4.2 Existing Patient View Profile On the landing page Patients List click the Magnifying Glass icon You can review Patient Profile data in read only mode You can also review the Patient s Treatment history presented as Prescription Lines grouped by epaf ID
4.3 Existing Patient Update Profile On the landing page Patients List click the pencil icon On the Patient Edit page you are able to change: Institution assignment within the same country Risk Category assignment Please note a change in the Risk Category has to be acknowledged Click Save Changes to update the Patient s data
4.4 Existing Patient epaf creation On the landing page you will see a list of patients for the relevant institution Click the + icon in the Actions column to begin Prescription creation process
4.5 Existing Patient epaf creation Follow the process starting from the PIC step The PIC has been printed checkbox is pre-filled for existing patients and you do not have to download the PIC Tick Is private patient and Home care boxes if appropriate Enter pregnancy test date; a test date in excess of 3 days prior to epaf creation will trigger a violation Select the relevant Pregnancy Test Result; a positive test result will trigger a violation
4.6 Existing patient epaf creation The Indication and Treatment Stage will be pre-filled based on the last Dispensed epaf The cycle number will increase automatically based on the Patient s Treatment History Click the + icon to add a prescription line and follow normal epaf process Select the pharmacy to which the epaf will be sent Confirm your identity by entering your password; this is your signature authorising the epaf Click on Submit to send the epaf to the pharmacy
5. RMP UK & Ireland - epaf Prescriber Exceptional Dispensing & Positive Pregnancy Result
5.1 Exceptional Dispensing The Exceptional Dispensing process is triggered when a epaf contains more Treatment Cycles than are allowed: For the WCBP risk category this is any more than 1 (one) cycle For the Male or WNCBP risk categories this is any more than 3 (three) cycles The following information around the justification for Exceptional Dispensing should be provided for Celgene Medical Director approval: Reason How the patient will be monitored Stability of patient
5.2 Positive Pregnancy Test Result If you select a Positive Pregnancy Test Result the Celgene Drug Safety team will be notified and you will not be able to process the epaf further
6. RMP UK & Ireland - epaf Prescriber Resubmitting Rejected epafs
6.1 Resubmitting rejected epaf If a pharmacist rejects an epaf you submitted, you should follow these steps to edit and resubmit: On the Manage epafs page filter Prescriptions by Rejected status Review the epaf rejection information in the epaf information section Click Edit to begin the epaf resubmission process
6.2 Resubmitting rejected epaf During the epaf resubmission process a new epaf is created that supersedes the rejected one You should follow normal PIC and epaf process but please note On the PIC step only Risk Category can be changed On the epaf step the number of Treatment Cycles must be retained although the prescription lines count can be different
7. RMP UK & Ireland - epaf Prescriber Managing epafs
7.1 Displaying epaf list On the landing page select Manage epafs from the top navigation menu On the Manage epafs page use left hand filter menu to narrow the results by epaf status Use clickable headers to additionally filter and sort epafs Use Actions buttons to: View epaf details Navigate to Rejected epaf that given epaf supersedes
7.2 Viewing epaf details On the Manage epafs page use Magnifying Glass icon to navigate to epaf details page
7.3 Viewing epaf details On the Manage epafs page use Magnifying Glass icon to navigate to epaf details page Use Display Treatment History button for displaying Treatment History pop-up window
7.4 PPP due soon notification Whenever a new version of the PPP document is introduced you will be notified You can then download the new version of the document
8. RMP UK & Ireland - epaf Prescriber Password management
8.1 Forgot Password From the login page select Forgot Password to start password reset process Provide your email address and click Submit On the next screen provide the answer to your security question and click Submit You will receive an email with a temporary password; please use it the same way as during first time login
8.2 Change Password Use drop down menu from the right top corner Select Change Password Provide current application password Set a new password than differs from the current one Submit data
9. RMP UK & Ireland - epaf Prescriber Reporting Adverse Event
9.1 Accessing Adverse Event Report You can access the Adverse Event Report from the following screens epaf details page available from Manage epafs tab Patient details page available from Patient list on the landing page Click the link to launch the Adverse Event pop-up screen.
9.2 Adverse Event Report Click the link to download the Adverse Event Report Form Open the document Fill in the required fields Print the document if necessary Send the report to Celgene Email address for Adverse Event reporting is drugsafetyuk@celgene.com