Safety measures and the Early Access to Medicines Scheme

There are safety measures in place if you have a drug through the Early Access to Medicines Scheme (EAMS).

Safety

The drugs in the EAMS scheme are new. So researchers are still finding out about how well they work and what side effects they cause. This means you may have side effects that doctors don't know about yet.

Reporting to the MHRA

The drug company provides regular updates to the MHRA. This is to check how well the new medicine works. The updates also include any side effects. The company has to do this as part of their agreement to be able to supply the medicine. They give reports at least every 3 months, but for some drugs, it might be more often.

Reporting to the pharmaceutical company

Your doctor will give the pharmaceutical company regular updates. These include the results of any tests and side effects you have. If you have any serious side effects, your doctor, nurse or pharmacist need to report them within 24 hours. They should report any other effects within 5 days.

Patient Alert Card

Your doctor will also give you a Patient Alert Card. You should carry this card with you at all times. The card has information about the drug you are taking and its known side effects. It has the contact details for your cancer doctor and specialist nurse.

Which drugs are available on EAMS

This scheme started in early 2014 and the MHRA has only looked at a few drugs.

What to do if you want an EAMS drug

Talk to your doctor if you think that an EAMS drug is suitable for you. If you want to have an EAMS drug and your doctor agrees, your doctor applies to the manufacturer and your local NHS.

You might feel disappointed if you can’t have the treatment you would like. This can be very difficult to come to terms with. You might feel a range of emotions, including anger.

It can be helpful to talk to your specialist. Ask them whether there are other treatments you can have or if you can take part in a clinical trial.

You might be able to talk with other people who have tried to get the same treatment. It can be helpful to share experiences.