Supporting safer medications
What are drug safety studies?
Before a medication is approved for patients, it is tested in clinical trials to make sure it is safe and effective. However, the conditions in which drugs are studied in clinical trials may not reflect the way they are used after they have been approved. This means it is important to continue monitoring the use of medications for as long as they are available. This is called pharmacovigilance. The Medicines and Healthcare products Regulatory Agency (MHRA) has more information about this.
Drug safety studies are an important part of this work. These studies involve the ongoing collection and analysis of real-world hospital information about a particular drug that has been approved for use by patients. They are observational studies, meaning they monitor and record any effects that may be related to the use of the drug being studied.
How does the IBD Registry support drug safety studies?
We aim to help improve quality of life for people with IBD in the UK by collecting and analysing patient data, including information that patients taking certain drugs may report to their hospital care teams. This is known as an observational study because it simply monitors and reports what is happening, without taking any actions that might impact the study.
We have established an observational drug safety study programme to monitor a range of medications for treating IBD. Our programme allows IBD hospital teams to capture information that may be related to specific treatments used by their patients. Participating hospital teams and the Registry receive funding from pharmaceutical companies to set up and carry out this work. By collecting data reported by patients to their doctor or nurse as part of their routine care, the Registry acts as a key information source for pharmacovigilance. We only do this with patients’ permission (see below). Our drug safety study data is combined with others in the UK and internationally to form a large database that allows pharmaceutical companies and hospitals to monitor the safety of drugs once they have been approved for use.
How can I be involved?
We encourage hospital teams to participate in our drug safety programme as the more data we collect, the more closely the evidence we gather will reflect the real-world effects of different treatments. You may be asked by your doctor or nurse if you want to take part. If you do, you can give your written consent for your data to be used in the study. Only data from patients who have given their consent will be used. If you are taking one of the drugs we are observing and you want to be involved, talk to your IBD doctor or nurse to find out if your hospital is part of the study.
Will it affect my treatment?
If you participate, there is no effect on the treatment you receive. These studies are observational – this means that we monitor the data provided by your hospital without making any changes to how treatments are used.
Is my medication being studied?
Currently, we are carrying out drug safety studies on the following medications:
- Zessly (infliximab)
What if my medication isn’t being studied by the Registry?
If you have experienced negative side effects from any medication, you can report this to the Yellow Card scheme. The scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) to make sure that medicines and medical devices standards. It relies on voluntary reporting of any suspected side effects by healthcare professionals or members of the public.