Risk Materials

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

Thalidomide Adverse Event Form

The safe use of thalidomide is of paramount importance. Adverse events (and cases of suspected or confirmed pregnancy or foetal exposure) should be reported to BMS. You can also report the event online via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Thalidomide Healthcare Professional’s Information Pack

This pack contains the all the additional Risk Minimisation Materials required to prescribe and dispense thalidomide. It also contains important reporting forms, information for patients, prescribing tools, and the Pharmacy Registration Form. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing thalidomide for any patient.

For Healthcare Professionals

Thalidomide Information for Healthcare Professionals

This brochure contains the information needed for prescribing and dispensing of thalidomide, including information about the Pregnancy Prevention Programme. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing thalidomide for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for thalidomide.

For Healthcare Professionals

Thalidomide Information for Patients

This brochure should be given to patients receiving treatment with thalidomide, as it provides important information about the thalidomide Pregnancy Prevention Programme, including what a patient needs to be aware of before, during and after taking thalidomide and how to report side effects.

Thalidomide Male Treatment Initiation Form

This Treatment Initiation Form must be completed for each male patient prior to the initiation of their thalidomide treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of thalidomide. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of thalidomide.

Thalidomide Patient Pocket Information Card

This card should be given to all patient as it reminds patients of the key educational information and risks of treatment with thalidomide.

Thalidomide Pharmacy Registration Form

This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense thalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of thalidomide will only be allowed from pharmacies registered with BMS.

For Healthcare Professionals

Thalidomide Pregnancy Outcome Form

The safe use of thalidomide is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. You can also report the event via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Use this form to provide information about the outcome of pregnancy.

For Healthcare Professionals

Thalidomide Pregnancy Reporting Form

The safe use of thalidomide is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. You can also report the event via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

Thalidomide Prescription Authorisation Form

A newly completed Prescription Authorisation Form must accompany each thalidomide prescription to confirm that the patient has been counselled about the teratogenic risk of thalidomide and the required contraceptive methods, continues to use effective contraception and in the case of a woman of childbearing potential, is having a pregnancy test every 4 weeks before each prescription to ensure they are not pregnant. Completion of this information is mandatory for ALL patients.

For Healthcare Professionals

Thalidomide Treatment Checklists and Algorithm

This checklist is to assist you with counselling a patient before they commence thalidomide treatment in order to ensure it is used safely and correctly. The Algorithm provides high level steps for prescribing and dispensing of thalidomide.

For Healthcare Professionals

Thalidomide Woman of Childbearing Potential Treatment Initiation Form

This Treatment Initiation Form must be completed for each woman of childbearing potential prior to the initiation of their thalidomide treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of thalidomide. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of thalidomide.

Thalidomide Woman of Non-Childbearing Potential Treatment Initiation Form

This Treatment Initiation Form must be completed for each woman of non-childbearing potential prior to the initiation of their thalidomide treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of thalidomide. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of thalidomide.

For Healthcare Professionals

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