Risk Materials

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

Thalidomide Adverse Event Form

The safe use of this product is essential. Adverse events or any cases of suspected/confirmed pregnancy or foetal exposure should always be reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Thalidomide HCP 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. An easy reference guide is included at the back of the pack. This summarises the information for ongoing patient safety and the main steps in the Thalidomide Pregnancy Prevention Programme process.

For Healthcare Professionals

Thalidomide Information for Healthcare Professionals

This material contains the information need by the healthcare professionals for prescribing and dispensing Thalidomide, including information about the Pregnancy Prevention Programme (PPP). It is a requirement that the healthcare professional ensures they read and understand the PPP prior to prescribing and dispensing thalidomide to ANY patient. Please also refer to the Summary of Product Characteristics (SmPC) for thalidomide.

For Healthcare Professionals

Thalidomide Information for the Patients

This material should be given to each patient receiving treatment with thalidomide as it provides important details about the Pregnancy Prevention Programme, including what the patient needs to be aware of before, during and after taking thalidomide along with how to report any 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 all males receive counselling and education to be made aware of the risks of thalidomide. The aim is to protect the patient and any possible foetuses by ensuring the patient is fully informed of and understands the risk of teratogenicity and other adverse effects associated with the use of thalidomide.

For Healthcare Professionals

Thalidomide Patient Information Card

**New Card - Please destroy previous version** The patient card must be given to patients receiving treatment with thalidomide, as it provides important details about the Pregnancy Prevention Programme, including what they need to be aware of before, during and after taking thalidomide and how to report side effects.

Thalidomide Pharmacy Registration Form

The Pharmacy registration for must be completed by the chief Pharmacist or their appointed deputy to be able to order and dispense thalidomide. Pharmacies will only be able to dispense thalidomide if they are registered with Accord.

For Healthcare Professionals

Thalidomide Pregnancy Form

The safe use of this product is essential. Any cases of suspected pregnancy or confirmed pregnancy should be IMMEDIATELY reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Thalidomide Pregnancy Outcome Form

The safe use of this product is essential. Any cases of suspected pregnancy or confirmed pregnancy should be IMMEDIATELY reported to Accord. Any adverse events can also be reported direct to the MHRA via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

For Healthcare Professionals

Thalidomide Prescription Authorisation form

Each prescription of Thalidomide must be accompanied by a newly completed Prescription Authorisation Form to confirm the patient has been counselled about the teratogenic risk of thalidomide and the requirement for the use of contraception and the continuous use of an effective contraception whilst taking thalidomide. Also, for woman of childbearing potential the confirmation of 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 Checklist and Algorithm

The thalidomide checklist is to assist the healthcare profession with counselling a patient before the commence thalidomide treatment to ensure it is used safety and correctly. The Algorithm provides high level steps for the process of Pharmacy registration and dispensing of thalidomide.

For Healthcare Professionals

Thalidomide Women 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. Thalidomide is contraindicated in women of childbearing potential unless all terms of counselling are met. 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 thalidomide.

For Healthcare Professionals

Thalidomide Women 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 thalidomide.

For Healthcare Professionals

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