Assessment of Brand Name Prescribing of Biologics (IRAS Ref. 226131) Study

About the study:

Despite recommendations from national bodies, it is not known how widespread both brand name prescribing and batch number recording are across the UK and whether prescribing systems are adequately set up to track and trace brand name and batch number. The objectives of the study are to understand whether prescriptions for biologics for rheumatological conditions are issued using the brand name of a product and what relevant prescribing guidelines exist within local trusts.

My participation:

We would like to invite you to take part in the study by creating an account and registering. It is entirely up to you whether you participate but your responses would be valued. If you choose to register, you will be sent confirmation on how to participate in the survey.

What we ask you to do:

The survey will comprise three phases:

Phase I will request information about you and your site as part of study registration; this will require completion of a single online form and should take no more than 10 minutes. In recognition of the administrative work undertaken to complete this form, fair market value of £10 remuneration is available for completing study registration. This will be paid to the nominated representative within your trust.

Phase II will request survey information regarding prescriptions issued for patients receiving originator biologics and/or biosimilars for the treatment of rheumatological conditions. You will be asked to record whether the brand name of the originator biologic/biosimilar prescribed was written on the original prescription by the prescriber as well as whether the brand name and batch number were recorded at the dispensing stage. Multiple prescriptions may be surveyed (the most recent prescription only for each patient eligible). We are aiming for you to survey at least 22 originator biologics/biosimilar prescriptions from 22 patients who have been prescribed a biologic for a rheumatological condition in reverse chronological order, starting with the most recent and working backwards. A separate online form will need to be completed for each prescription and this should take about 20 minutes each. Remuneration of £15 is available for completion of each patient prescription survey in Phase II. This will be paid to the nominated representative within your trust.

Phase III will seek to gain more information around prescribing guidance within your site. A separate online form will be available after the end of the Phase II data collection period, and should take about 15 minutes to complete. If you could not find the relevant information during Phase II, we are interested in the reasons for this, so there will be opportunities available for you in Phase III to describe your challenges. Remuneration is available of £15 for completion of Phase III. This will be paid to the nominated representative within your trust.

By registering on the website, your consent to participate is assumed. The DSRU would like to reassure you that any information you give about yourself in Phase I and Phase III will be treated in confidence. The responses for the Phase II form will be completed anonymously without reference to patient names. All reasonable steps will be taken to ensure confidentiality. This research follows principles of good scientific practice and any information you give will simply be added to the answers received from others to provide an overall picture.

Any adverse event will be reported to AbbVie, by a member of the care team within 24 hours of becoming aware.

Report To:
E-mail: ukadverseevents@abbvie.com
Phone: 01628 561092