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UK-MM130072 date of prep April 2014 Risk Management Programme (RMP) UK & Ireland electronic Prescription Authorisation Form (ePAF) User Guide

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Page 1: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

UK-MM130072 – date of prep April 2014

Risk Management Programme

(RMP) UK & Ireland –

electronic Prescription

Authorisation Form (ePAF)

User Guide

Page 2: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

UK-MM130072 – date of prep April 2014

Head Pharmacist Self-registering in the ePAF system

1. RMP UK & Ireland - ePAF

Page 3: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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You will need to

register to use the

ePAF system.

• Browse to the ePAF

UK website

• https://ermp-

ukire.celgene.com

• On the login screen

click Register to start

the self-registration

process

1.1 Starting self-registration process

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• Select Head Pharmacist from the

User type drop-down box then click

next.

• Select relevant country from the

Country drop-down box then click

next

• Fill in your Contact Information

• A Validate button will appear when

you have entered all of your details

including GPhC /PSNI number.

Please note 4 digit PSNI number

needs to be preceded by Q000.

This performs a check with a third-

party provider and is optional at this

point. The validation will be done

automatically when you click register

at the end of the registration process.

• Click Next to continue

1.2 Self-registration

Page 5: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Click the Add button to

open the Pharmacy

creation pop-up

• Fill in Pharmacy

information

• Choose apropriate

Logistical Service

Provider

• Click the Choose button

to open Institutions List

and select institutions

that are associated with

this Pharmacy

• Select Celgene

Products that the

Pharmacy handles

1.3 Self-registration – Pharmacy creation

Page 6: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• After completion of

adding pharmacies click

the Register button to

finalise process

• Check your email

account inbox for an

email containing a

temporary password

• Navigate to login page

1.4 Self-registration

Page 7: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Additional Pharmacist Self-registering in the ePAF system

2. RMP UK & Ireland - ePAF

Page 8: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

UK-MM130072 – date of prep April 2014

You will need to

register to use the

ePAF system.

• Browse to the

ePAF UK website

• https://ermp-

ukire.celgene.com

• On the login screen

click Register to

start the self-

registration process

2.1 Starting self-registration process

Page 9: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Select Additional Pharmacist from the User

type drop-down box then click next

• Select relevant country from the Country

drop-down box and click next

• Fill in your Contact Information

• A Validate button will appear when you have

entered all your details including GPhC/

PSNI number. Please note 4 digit PSNI

number needs to be preceded by Q000

number. This performs a check with a third-

party provider and is optional at this point.

The validation will be done automatically

when you click register

• Click the Choose button to open Pharmacy

selection pop up

• Choose Pharmacies you are working for

• Review Celgene Products list for selected

Pharmacies

• Proceed by clicking Register

2.2 Self-registration

Page 10: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• After completion of adding

pharmacies click Register

to finalise process

• Check your email account

inbox for an email

containing temporary

password

• The email will include

‘Celgene ePAF’ in the

subject line and the sender

will be

[email protected]

• Navigate to login page

2.3 Self-registration

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Head Pharmacist, Additional Pharmacist First time login

3. RMP UK & Ireland - ePAF

Page 12: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Enter your email

address and

temporary

password to login

for the first time

3.1 First time login

Page 13: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• After logging in

for the first time

you will be

promted to

change your

password and

select a security

question and

answer.

3.2 First time login - Security settings

Page 14: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Once the password is changed

you will be prompted to

download and accept the

Pregnancy Prevention

Programme (PPP) documents

• The documents you are

prompted to download are

dependent on the products

handles at the selected

pharmacy.

• This prompt will be also

displayed if new versions of the

PPP documents are available in

the system

• You will also be prompted to

download and accept the PPP

documents after 2 years as per

the PPP regulations

3.3 Confirm PPP documents

Page 15: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Once the PPP

documents have

been accepted, a

pop-up window is

displayed to choose

current Pharmacy

• Every further action

in the system will be

executed in the

context of selected

Pharmacy

3.4 Select current Pharmacy

Page 16: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Accessing the ePAF system

4. RMP UK & Ireland - ePAF

Page 17: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• You can access the

ePAF system using any

of the following

browsers

– Internet Explorer

versions 7 and newer

– Firefox

– Chrome

– Safari

• Access to the ePAF

system is secured by

HTTPS protocol

4.1 Accessing the ePAF System

Use the URL https://ermp-ukire.celgene.com. Then enter your email address and

password to access the system

Page 18: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Landing Page

5. RMP UK & Ireland - ePAF

Page 19: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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•On the navigation tab there

are links to available pages:

– Home (landing page)

– Account Approval

(visible only for Head

Pharmacist)

– Manage ePAFs (for

prescriptions managment)

– Stock Replenishment

5.1 Landing Page overview

Page 20: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist Additional Pharmacist - Account Approval

6. RMP UK & Ireland - ePAF

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• From the landing page

select ’Account Approval’

top navigation link

• The list contains newly

registered and not yet

approved Additional

Pharmacist accounts, as

well as previously

rejected accounts

• Status column indicates

the status of a request

(pending or rejected)

• Actions column allows

you to view account

detail and perform an

action

• Column headers allow

you to filter and sort data

6.1 Account Approval list

Page 22: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Page contains account

details

• Close button redirects

user to Account Approval

list

• Reject button rejects

account approval request

to curently selected

Pharmacy – Rejection will be prompted

for confirmation and

explanation

• Approve button approves

account request to

currently selected

Pharmacy – Approval will be prompted

for your confirmation

6.2 Account Approval - details

Page 23: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Previously rejected

request’s can be

approved

• Approval will be

prompted for

confirmation

• System will send

notfication email to

user’s email address

for both the approve or

reject action

6.3 Account Approval – for already rejected

account

Page 24: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Landing Page

7. RMP UK & Ireland - ePAF

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7.1 Landing Page elements •Prescriptions list

(Waiting ePAFs)

– Scoped to the current

Pharmacy

– Status column indicates

ePAFs only in ‘Waiting

Approval’ status

– Actions column allows

you to view prescription

details

– Column headers allows

you to filter and sort data

– If the user is a home care

pharmacist, then the list

of PAFs will only display

those PAFs that are

flagged with “Allow Home

Dispensing”

Page 26: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Replenish Stock top

navigation link starts the

process of creating new

Replenishment Stock

order

• Account Approval top

navigation link will redirect

you to a page containing

list of new pharmacists

accounts scoped to the

current Pharmacy

• Manage ePAFs top

navigation link will redirect

you to a page containing

the ePAF list scoped to the

current Pharmacy

• Stock Replenishment top

navigation link will redirect

you to a page for creating

new replenishment stock

order

7.2 Landing Page elements

Page 27: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Footer links will take

you to selected content

page

• Pages available: – Contact Us

– Privacy Policy

– Terms of User

– Help

7.3 Landing Page elements

Page 28: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Managing ePAFs

8. RMP UK & Ireland - ePAF

Page 29: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• On the landing page

select Manage ePAFs

from the top navigation

menu

• On the Manage ePAFs

page use the left hand

filter menu to narrow

the results by PAF

status

• Use the clickable

headers to additionally

filter and sort PAFs

• Use Actions buttons to

view ePAF details

8.1 Displaying ePAF list

Page 30: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• On the Manage ePAFs

page use Magnifying

Glass icon to navigate

to the PAF details page

8.2 Viewing ePAF details

Page 31: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Approval process can be

only performed on

prescription with ‘Submitted’

status

• If the currently logged on

Pharmacist is allowed to

handle product prescribed on

prescription, buttons for

approve and reject on the

bottom will be available (in

other case only ‘Close’

button)

8.3 View ePAF

Details and

approval

Page 32: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Confirmation for prescription

approval is prompted when

button is clicked

• Observe that the Pharmacist

is redirected to the landing

page with a notification

visible at the top of the page

8.4 View ePAF Details

and approval

Page 33: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• The Rejection process can

be only performed on

prescription with ‘Submitted’

status

• If the currently logged on

Pharmacist is allowed to

handle product prescribed

on prescription ‘Reject’

button will be available

• The Pharmacist can reject

the PAF due to invalid

information

8.5 View ePAF

Details and

rejection

Page 34: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Confirmation for prescription

rejection and reason is

prompted when button is

clicked

• Observe that the Pharmacist is

redirected to the landing page

with a notification visible at the

top of the page

8.6 View ePAF Details

and rejection

Page 35: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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8.7 View ePAF

Details and

dispense

• Dispense process can be

only performed on

prescription with Approved’

status

• If the currently logged on

Pharmacist is allowed to

handle product prescribed on

prescription, buttons for

Dispense and Stock

Replenishment on the bottom

will be available (in other

case only ’Close’ button)

• The Pharmacist is informed

that by clicking ‘Dispense’

they confirm stock availability

Page 36: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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8.8 View ePAF Details

and dispense

• The Dispense date popup window

appears on button click

• Confirmation for prescription dispense

is prompted when button is clicked

• Observe that Pharmacist is redirected

to the landing page with a notification

visible at the top of the page

Page 37: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Password Management

9. RMP UK & Ireland - ePAF

Page 38: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• From the login page click

Forgot Password to start

password reset process

• Provide email address and

click Submit

• On the next screen provide an

answer to security question

and click Submit

• You will receive email from

[email protected] , subject

‘Celgene ePAF: Your

password has been reset’, with

a temporary password and be

prompted to change this in the

same way as your first time

login

9.1 Forgotten Password

Page 39: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Use the drop down

menu from the right top

corner

• Select Change

Password

• Provide current

application password

• Set a new password

that differs from the

current one

• Submit data

9.2 Change Password

Page 40: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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Head Pharmacist, Additional Pharmacist Reporting Adverse Event

10. RMP UK & Ireland - ePAF

Page 41: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Adverse Event Report

feature is accessible from:

– PAF details page

available from Manage

ePAFs tab

10.1 Accessing Adverse Event Report

Page 42: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• On the Adverse Event pop-up

window click the link to

download the PDF document

• Open PDF document

• Fill in required fields

• Print it

• Send the report to Celgene via

email

[email protected]

10.2 Adverse Event Report

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Head Pharmacist, Additional Pharmacist Updated PPP Document

11. RMP UK & Ireland - ePAF

Page 44: Risk Management Programme (RMP) UK & Ireland electronic ...nssg.oxford-haematology.org.uk/...pharmacist-v3.pdf · • The list contains newly registered and not yet approved Additional

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• Whenever a new

version of the PPP

document is introduced

the Head Pharmacist

will be notified.

• You can download the

new version of the

document

11.1 PPP due soon notification